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FDA, EU MDR, & ISO Compliance Software & Application Lifecycle Management (ALM) - Ketryx
Build with FDA compliance and ALM software 3x faster with Ketryx Compliance Framework. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11
Articles & Blog Posts (334)
Long-form content, blog posts, and editorial pieces
Ketryx Certifications - Ketryx
The development and control of Ketryx Platform software for building medical products to IEC 62304. Incorporating software development planning including identification and management of software h...
🟩 Certifications Request Form
About Ketryx Certifications Certified to international standards for compliance Request Certification Documentation Are You Building Medical Software? Get started building software in minutes, not mon
About Ketryx | Company Information - Ketryx
What if regulated teams could release high-quality products at the same speed as unregulated industries? Ketryx CEO and Founder Erez Kaminski ...
Ketryx In the News - Ketryx
Newsroom The latest news on Ketryx Get to know the latest stories from and about Ketryx In the News Press Releases Analyst Reports Watch how Ketryx applies AI to automate compliance in regulated softw
Why Ketryx - Ketryx Compliance Framework
Industry expertise includes AI/ML, regulatory, and former FDA talent
AI San Diego Meetup - Ketryx - Unburdening Builders
Connect with life sciences innovators and learn how to validate AI faster so you can bring life-changing technology to patients sooner.
A Playbook for Transforming Jira to Support IEC 62304 Compliance - Ketryx
White Paper A Playbook for Transforming Jira to Support IEC 62304 Compliance Are You Building Medical Software? Get started building software in minutes, not months.Book a demo
https://www.ketryx.com/assets/a-playbook-for-transforming-jira-to-support-iec-62304-compliance
A Guide To Implementing CI/CD in Your AI/ML SaMD Projects - Ketryx
White Paper A Guide To Implementing CI/CD in Your AI/ML SaMD Projects Are You Building Medical Software? Get started building software in minutes, not months.Book a demo
Discover Why Traceability Doesn't Have to Be So Hard - Ketryx
White Paper Discover Why Traceability Doesn't Have to Be So Hard Are You Building Medical Software? Get started building software in minutes, not months.Book a demo
https://www.ketryx.com/assets/discover-why-traceability-doesnt-have-to-be-so-hard
FDA Cyber Guidance and the Software Supply Chain - A Playbook for Shifting Left - Ketryx
White Paper FDA Cyber Guidance and the Software Supply Chain - A Playbook for Shifting Left Are You Building Medical Software? Get started building software in minutes, not months.Book a demo
FDA PCCP Compliance Guide - Ketryx
White Paper FDA PCCP Compliance Guide Are You Building Medical Software? Get started building software in minutes, not months.Book a demo
IDC Spotlight: Connected Life-Cycle Management Streamlines Software Development for Medical Devices - Ketryx
White Paper IDC Spotlight: Connected Life-Cycle Management Streamlines Software Development for Medical Devices Are You Building Medical Software? Get started building software in minutes, not months.
IEC 62304 Compliance Checklist - Ketryx
White Paper IEC 62304 Compliance Checklist Are You Building Medical Software? Get started building software in minutes, not months.Book a demo
https://www.ketryx.com/assets/iec-62304-compliance-checklist
Inside the FDA Regulatory Process - Ketryx
White Paper Inside the FDA Regulatory Process Are You Building Medical Software? Get started building software in minutes, not months.Book a demo
https://www.ketryx.com/assets/inside-the-fda-regulatory-process
JavaScript Static Analysis Tools for Medical Devices - Ketryx
White Paper JavaScript Static Analysis Tools for Medical Devices Are You Building Medical Software? Get started building software in minutes, not months.Book a demo
https://www.ketryx.com/assets/javascript-static-analysis-tools-for-medical-devices
FDA Predetermined Change Control Plan (PCCP) Template - Ketryx
Thanks for your interest in our FDA Predetermined Change Control Plan (PCCP) Template. Here are two versions of the template to choose from:
QMS Optimization Workshop Template - Ketryx
White Paper QMS Optimization Workshop Template Are You Building Medical Software? Get started building software in minutes, not months.Book a demo
https://www.ketryx.com/assets/qms-optimization-workshop-template
Regulatory Pathways - Ketryx
White Paper Regulatory Pathways Are You Building Medical Software? Get started building software in minutes, not months.Book a demo
SaMD Regulatory Requirements - Ketryx
White Paper SaMD Regulatory Requirements Are You Building Medical Software? Get started building software in minutes, not months.Book a demo
The Cost of Quality - Ketryx
White Paper The Cost of Quality Are You Building Medical Software? Get started building software in minutes, not months.Book a demo
Modernizing FDA-Grade Software Development with Validated DevOps - Ketryx
White Paper Modernizing FDA-Grade Software Development with Validated DevOps Are You Building Medical Software? Get started building software in minutes, not months.Book a demo
$14M to Build the Future of Medical Software
New, innovative software continues to disrupt and transform society as we know it, including solving big problems, squeezing out new efficiencies and creating a better quality of life.
https://www.ketryx.com/blog/14m-to-build-the-future-of-medical-software
2023 FDA Warning Letters and Software Validation
In the past year, we have witnessed a surge in FDA software-related announcements – including everything from new guidances to warning letters. These initiatives reflect the FDA’s increased focus o...
https://www.ketryx.com/blog/2023-fda-warning-letters-and-software-validation
21 CFR Part 11 Compliance Guide for Jira (Atlassian)
FDA 21 CFR Part 11, also known as Part 11, are complex regulations all medical device software companies (and other companies under FDA regulation) in the United States must comply with. Part 11 re...
https://www.ketryx.com/blog/21-cfr-part-11-compliance-guide-for-jira-atlassian
39 Millionen Dollar Investment für österreichisch-amerikanisches KI-Start-up
In der breiten Masse ist das Start-up Ketryx eher unbekannt – kein Wunder, richten sich die Produkte doch eher an eine Nische im B2B-Bereich: Das österreichisch-amerikanische Unternehmen bietet KI-...
A brief overview of cloud security for standard and safety-critical software
The cloud is a network of remote servers that store, manage, and process data, making it easy to access from anywhere with an internet connection. While the benefits of cloud computing are numerous...
https://www.ketryx.com/blog/a-brief-overview-of-cloud-security
A Complete Guide to the FDA’s AI/ML Guidance for Medical Devices
Artificial intelligence (AI) and machine learning (ML) technologies are rapidly transforming healthcare by extracting critical insights from the enormous amounts of data generated in the healthcare...
https://www.ketryx.com/blog/a-complete-guide-to-the-fdas-ai-ml-guidance-for-medical-devices
A Comprehensive Guide to IEC 62304: Navigating the Standard for Medical Device Software
In the rapidly evolving world of medical technology, software plays an increasingly critical role in the functionality and safety of medical devices. Ensuring that this software meets stringent saf...
Achieve faster product releases with Ketryx's validated AI agents
This article originally appeared in Today's Medical Developments on May 2, 2025.
https://www.ketryx.com/blog/achieve-faster-product-releases-with-ketryxs-validated-ai-agents
Ketryx’s New Integration with Azure DevOps (ADO): End-to-End Traceability for Regulated Teams
One of the biggest challenges we see regulated teams face is coordinating work across systems. Systems engineers and product marketing often use a dedicated tool to manage requirements and system-l...
Agile in Theory, Waterfall in Practice: Why Regulated Teams Struggle to Ship Fast
Most regulated teams want to be as agile as unregulated teams.
AI Agents Launched to Streamline Compliance in Safety-Critical Sectors
This article originally appeared in the AI Business Newsletter on May 2, 2025.
https://www.ketryx.com/blog/ai-agents-launched-to-streamline-compliance-in-safety-critical-sectors
How Quality Teams Are Using AI Agents to Scale Their Impact
Agentic AI is quickly becoming a critical enabler for regulated teams that want to scale quality and compliance without slowing down development.
AI Experts Network: Innovation Labs Series
This article originally appeared in AI Expert Network on August 4, 2023.
https://www.ketryx.com/blog/ai-experts-network-innovation-labs-series
AI firm Ketryx raises $39M, adds former Medtronic CEO as investor
As the Food and Drug Administration regulates a growing number of software and AI tools, the agency is also clarifying regulatory requirements. For example, the FDA has opened a pathway for pre-det...
https://www.ketryx.com/blog/ai-firm-ketryx-raises-39m-adds-former-medtronic-ceo-as-investor
AI startup that streamlines medical device compliance raises $39M
A Boston-based startup aiming to make medical device compliance easy and seamless has received $39 million in venture capital funding.
https://www.ketryx.com/blog/ai-startup-that-streamlines-medical-device-compliance-raises-39m
Announcing Ketryx’s UL Certification to IEC 62304, ISO 13485, and ISO 14971
In highly regulated settings such as the medical device industry, compliance with international standards is vital to help ensure that medical devices are safe for use. Compliance also serves to op...
https://www.ketryx.com/blog/announcing-ketryxs-ul-certification
As FDA moves builds out ‘Elsa,’ this AI compliance CEO underscores that need for a hybrid AI approach
This article originally appeared in R&D World on June 16, 2025.
Best Practices for Maintaining a Requirement Traceability Matrix in Agile
Agile methodologies have become the go-to approach for their ability to enhance collaboration, flexibility, and productivity as software development demands faster releases. In Agile, the Requireme...
Beyond the Basics: Building FDA-Compliant SBOMs for MedTech
In medical technology, the security of devices isn't just about safety; it's also about cybersecurity. From patient data breaches to the potential hijacking of equipment, the cybersecurity vulnerab...
https://www.ketryx.com/blog/building-fda-compliant-sboms-for-medtech
Building the Infrastructure for Regulated AI: Announcing Ketryx's $39M Series B
Click for sound2:33
Why Change Impact Assessment Is the Hidden Bottleneck in Medical Device Development
In regulated medical device development, change is inevitable. Whether it’s a CAPA finding, new characterization test results, or market insight driving a design update, changes happen throughout t...
https://www.ketryx.com/blog/change-impact-assessment-bottleneck
Creating FDA-compliant Medical Devices at Lightning Speed with ChatGPT and Ketryx
Creating medical software is a challenging process, but recent advancements in software technology have made it more manageable. One platform that's changing how people design, develop and deploy m...
Clinical Trial Computerized Systems Regulation Review
The purpose of this regulation review is to summarize and provide commentary on the latest guidance released by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for th...
https://www.ketryx.com/blog/clinical-trial-computerized-systems-regulation-review
Computer Software Assurance
The FDA’s new guidance is the catalyst for a generational shift in software development for manufacturing systems and products in medical devices, pharmaceuticals, and biotechnology. But what exact...
Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development
Software developers in regulated industries often feel encumbered by inflexible procedures, training requirements, and work stoppages that slow down their workflows.
https://www.ketryx.com/blog/constructive-constraints-enforcement-faster-medical-software-development
Digital health's top 2023 trends, wrapped
Across 2023, certain topics in digital health landed at the top of our most-played hits: GLP-1s and obesity care, AI in healthcare, and “retailers as providers” to name a few. With a new year just ...
https://www.ketryx.com/blog/digital-healths-top-2023-trends-wrapped
Why Obsessing Over Documentation Might Be Making Your Product Less Safe
In the life sciences, documentation is synonymous with safety. But what happens when your team becomes so focused on formatting documents that they miss flaws in the product itself?
How to Build Compliant Software Faster with Polarion, Jira, and Ketryx
Medical device software is growing in complexity, driven by AI/ML, mobile applications, cloud connectivity, and increasingly modular architectures. At the same time, software team productivity in M...
https://www.ketryx.com/blog/doing-agile-development-with-jira-and-polarion
FDA Class I Medical Device Regulations and Compliance
The intricate world of medical device compliance and regulations can be daunting, particularly for manufacturers of Class I medical devices. Often perceived as less complex due to Class I devices b...
https://www.ketryx.com/blog/fda-class-i-medical-device-regulations-and-compliance
FDA Class II Medical Device Regulations and Compliance
Class II medical devices are defined by their moderate-to-high risk profile. According to 2017 data from the FDA, these medical devices, such as powered wheelchairs or contact lenses, consist of 43...
https://www.ketryx.com/blog/fda-class-ii-medical-device-regulations-and-compliance
FDA Cybersecurity Guidance for Medical Devices
As medical devices become increasingly interconnected, they also become more vulnerable to cybersecurity threats. Recognizing this critical concern, the FDA has released comprehensive cybersecurity...
https://www.ketryx.com/blog/fda-cybersecurity-guidance-for-medical-devices
FDA Cybersecurity SBOM Regulations and Compliance Guide
Cybersecurity has been an ever-increasing area of focus for the FDA and other national regulatory bodies. It’s simple to see why: as medicine increasingly becomes digital, patient safety will depen...
FDA Software Verification vs. Validation: What's the Difference?
In medical device development, where patients’ lives are at stake, ensuring the safety and efficacy of both software and hardware is paramount. Whether software controls a device, runs diagnostics,...
https://www.ketryx.com/blog/fda-software-verification-vs-validation-whats-the-difference
Former Medtronic CEO joins $39M Ketryx funding round
Ketryx offers an artificial-intelligence-powered compliance platform for medical device companies and other life sciences firms, saying it “automates validation, traceability, and regulatory workfl...
https://www.ketryx.com/blog/former-medtronic-ceo-joins-39m-ketryx-funding-round
Four Bold Predictions for Medtech in 2025: AI Everywhere, Faster Releases, and Rising Risks
This article originally appeared in MPO News on December 18, 2024.
From Recalls to Reliability: Tools to Ensure Software Safety in MedTech
This article originally appeared in Medcity News on June 14, 2024.
https://www.ketryx.com/blog/from-recalls-to-reliability-tools-to-ensure-software-safety-in-medtech
How Can Medtechs Prepare for the FDA’s Shift Left Strategy on Cybersecurity?
This article originally appeared in MedCity News on May 10, 2023. The recent FDA guidance on security marks good and bad news for the industry. In short, the FDA can now refuse submissions from m...
How Connected Lifecycle Management Is Revolutionizing MedTech Software Development
Application Lifecycle Management (ALM) tools were originally designed to manage the development and maintenance of simple software components that existed as part of hardware systems. But today’s s...
How Flo Health Built FDA-Ready Infrastructure Without Slowing Innovation
This article originally appeared in Femtech Insider on December 11, 2025.
https://www.ketryx.com/blog/how-flo-health-built-fda-ready-infrastructure-without-slowing-innovation
How Ketryx Works: Product Design Philosophy and Framework
For most companies, releasing FDA-regulated software products is very difficult due to fragmented, siloed tools and high levels of manual work required to ensure quality and compliance. As a result...
https://www.ketryx.com/blog/how-ketryx-works-product-design-philosophy-and-framework
How MedTechs Can Retain Developers
Medical device software development is a dream job that combines innovation with purpose for many developers. But what happens when that dream gets bogged down by compliance inefficiencies and lega...
https://www.ketryx.com/blog/how-medtechs-can-retain-developers
How Regulated Teams Release Every Two Weeks
Compliance shouldn’t mean slow.
https://www.ketryx.com/blog/how-regulated-teams-release-every-two-weeks
How to Build Safer and More Reliable Software
This article originally appeared in BuiltIn on June 14, 2023.
https://www.ketryx.com/blog/how-to-build-safer-and-more-reliable-software
How to Create a Design History File (DHF) for Medical Devices
The Design History File (DHF) is a critical component of the medical device design and development process. Required by the FDA and other regulatory bodies, the DHF ensures that medical devices are...
https://www.ketryx.com/blog/how-to-create-a-design-history-file-dhf-for-medical-devices
How to generate an SBOM (Software Bill of Materials) fast
A software bill of materials (SBOM) derives from the traditional use of a bill of materials (BOM) in manufacturing, which catalogs the raw materials and components of a product. An SBOM is a comple...
https://www.ketryx.com/blog/how-to-generate-an-sbom-software-bill-of-materials-fast
How to Stop Managing Documents and Start Managing the Work
For decades, regulated teams have treated documentation as the work. But what if documentation simply reflected the work that’s already been done?
https://www.ketryx.com/blog/how-to-stop-managing-documents-and-start-managing-the-work
How to Survive FDA’s Predetermined Change Control Plan
This article originally appeared in MD+DI on September 10, 2024. It’s rare to hear the private sector applauding a regulatory agency, but the FDA’s Predetermined Change Control Plan (PCCP) deserves...
https://www.ketryx.com/blog/how-to-survive-fdas-predetermined-change-control-plan
How to Validate Ketryx
If you work in a regulated space (medical devices, diagnostics, pharma, digital health), you know that validation is a fact of life. You need to show that your tools and systems do what they say th...
IEC 62304 & Requirements Traceability Matrix (RTM) in Jira: A Guide for Medical Device Companies
IEC 62304 defines the software development lifecycle (SDLC) processes for medical device software. With traceability as a main component of this standard, the challenge companies often face is how ...
Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices: A Comprehensive Guide
In light of recent FDA draft guidance, aligning predetermined change control plans (PCCP) with continuous integration and continuous delivery (CI/CD) pipelines has become increasingly crucial. Ketr...
Innovation Beat: Mass. unveils plan to improve EV charging. Is it moving fast enough?
💡 Energy storage startup Malta in Cambridge raised $22 million of $75 million it is seeking in equity financing, according to a securities filing. The company said investors included Siemens Energ...
Inside Ketryx’s Customer Validation Package
Standards, regulations, and guidances such as ISO 13485, 21 CFR 820, and the FDA Guidance on Computer Software Assurance for Production and Quality System Software require validation of any softwar...
https://www.ketryx.com/blog/inside-ketryxs-customer-validation-package
ISO 14971: A Comprehensive Guide to Risk Management in Medical Devices
For teams building medical devices, ensuring the safety and efficacy of medical devices is crucial. This is where ISO 14971 comes into play. As the internationally recognized standard for risk mana...
https://www.ketryx.com/blog/iso-14971-a-comprehensive-guide-to-risk-management-in-medical-devices
Ketryx 2.0 Release
Today, Ketryx, the leader in Application Lifecycle Intelligence enabling FDA-regulated software development teams to release 3 times faster, announced the release of Ketryx 2.0, which enhances the ...
Ketryx 2.11
Ketryx version 2.11 is here, bringing powerful new features in traceability, security, and control for life sciences teams. This release underscores our commitment to helping teams work fast and st...
Ketryx 2.5
We are excited to launch Ketryx 2.5, which introduces a set of new features that continue simplifying documentation and helping teams manage a complex software development lifecycle.
Ketryx 2.6
Developing regulated software is hard (but important!), and it’s even harder when you have to leave your favorite tools to manually update your RTM.
Ketryx 2.7
We built Ketryx to accelerate validated software development projects, decrease time to market, and ensure proactive post-market surveillance at scale. In order to do this, it’s vital that Ketryx p...
Ketryx 2.8
We are excited to announce the release of Ketryx 2.8, which is focused on enabling component reuse. While your product may be complex, Ketryx simplifies your workflows so that you can build a...
Ketryx 2.9
We’re excited to announce the release of Ketryx Version 2.9! The release of this new version makes our connected lifecycle management system even more powerful for medical device software teams. Th...
Ketryx AI Agents: How People and Agents Build Regulated Products Together
In regulated industries like life sciences and medical devices, quality isn't optional—it's safety-critical. But ensuring quality has often meant sacrificing speed and innovation. Product, engineer...
Ketryx: Application Lifecycle Management Company Raises $14 Million
The round was led by investor Lightspeed Venture Partners, with participation from existing investors including MIT’s E14 Fund and Ubiquity Ventures, bringing the total funding raised to date to ov...
https://www.ketryx.com/blog/ketryx-application-lifecycle-management-company-raises-14-million
Ketryx expands to larger Cambridge office as demand for AI agents grows
When Erez Kaminski set out to start his company, he wanted to make it the most boring software company anyone has ever built.
https://www.ketryx.com/blog/ketryx-expands-to-larger-cambridge-office-as-demand-for-ai-agents-grows
Ketryx Raises $14 Million to Boost Software Safety in Healthcare
This article originally appeared in Medical Design and Outsourcing News on December 5, 2023.
https://www.ketryx.com/blog/ketryx-raises-14-million-to-boost-software-safety-in-healthcare
Ketryx raises $14m in Series A funding
This article originally appeared in Med-Tech Innovation News on December 5, 2024.
https://www.ketryx.com/blog/ketryx-raises-14m-in-series-a-funding
Ketryx Raises $14M in Series A Funding
This article originally appeared in FinSMEs News on December 5, 2023.
https://www.ketryx.com/blog/ketryx-raises-14m-in-series-a-funding-2
Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners
Ketryx, provider of a connected application lifecycle management software for the life sciences industry, has announced that it has raised $14 Million in Series A funding.
https://www.ketryx.com/blog/ketryx-raises-14m-in-series-a-funding-led-by-lightspeed-venture-partners
Ketryx raises $18M to accelerate software development cycles in the medical industry
This article originally appeared in SiliconANGLE on December 5, 2024.
Ketryx raises $39 million in Series B funding to expand AI compliance tools for life sciences
Cambridge, Massachusetts–based Ketryx, a software platform company that automates regulatory compliance for medical device and life sciences companies, has secured $39 million in Series B funding l...
Ketryx Raises $39M Series B from Transformation & Lightspeed to Scale AI in MedTech
@MollySOShea·FollowBREAKING: Ketryx Raises $39M Series B from Transformation Capital & Lightspeed to Scale AI in MedTech Closed in just 14 days, this brings Ketryx's its total funding to $57M ...
Ketryx raises $39M to advance AI compliance in life sciences
Austrian-American Ketryx, the AI-powered compliance platform helping life sciences companies ship safer products faster, today announced a $39 million Series B, bringing the company’s total funding...
https://www.ketryx.com/blog/ketryx-raises-39m-to-advance-ai-compliance-in-life-sciences
Ketryx raises $39m to advance AI compliance platform
Ketryx has raised $39m to support the ongoing development of its AI-powered compliance platform.
https://www.ketryx.com/blog/ketryx-raises-39m-to-advance-ai-compliance-platform
Ketryx raises $39M to help medical device makers ship safer products faster
Ketryx Corp., a company transforming product lifecycle development and compliance for medical device makers with artificial intelligence, today announced it has raised $39 million in a Series B fun...
Ketryx Rakes In $14M to Speed Up Medical Device Development & Quality Assurance
The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower.
Ketryx Tackles Software Safety in Medical Devices Amid Growing Recalls
This article originally appeared in Medical Device Network on September 2, 2024.
https://www.ketryx.com/blog/ketryx-tackles-software-safety-in-medical-devices-amid-growing-recalls
Ketryx Wants Its Validated AI Agents To Accelerate Compliance Workflows
This article originally appeared in citeline.com on May 15, 2025.
https://www.ketryx.com/blog/ketryx-wants-its-validated-ai-agents-to-accelerate-compliance-workflows
Key Takeaways from the first Safety-critical Software Meetup in Boston
https://www.ketryx.com/blog/key-takeaways-from-the-first-safety-critical-software-meetup-in-boston
Mary Brook Delano Named Chief Business Officer at Ketryx
Ketryx has appointed Mary Brook Delano as chief business officer, a newly created role that is responsible for leading the company’s go-to-market strategy, revenue growth, customer experience, and ...
https://www.ketryx.com/blog/mary-brook-delano-named-chief-business-officer-at-ketryx
Medical Device Software Validation and Verification for Regulatory Compliance
In the realm of healthcare technology, Software as a Medical Device (SaMD) has emerged as a pivotal innovation, offering new avenues for diagnosis, treatment, and patient management. As SaMD increa...
Medtech AI developer Ketryx raises $14M in Series A round led by Lightspeed
This article originally appeared in Medical Design and Outsourcing News on December 5, 2023.
Medtech compliance — not regulation — is stifling innovation
This article originally appeared in STAT News on July 26, 2024.
https://www.ketryx.com/blog/medtech-compliance-not-regulation-is-stifling-innovation
Medtech Connect Episode 6: The Latest And Greatest In Digital Health Regulations
This article originally appeared in Citeline on June 9, 2023.
MedTech Trends for 2024: Takeaways from JP Morgan's Health Conference
With the new year just beginning, I was fortunate to attend the JP Morgan Health Conference 2024 to learn more about the trends shaping the healthcare and life science industry for the next twelve ...
https://www.ketryx.com/blog/medtech-trends-for-2024-takeaways-from-jp-morgans-health-conference
Can MedTech Use Validated DevOps to Move as Fast as Netflix?
Software development is moving faster than ever due to the widespread adoption of agile, iterative methods. This allows unregulated businesses to ship software at unprecedented speed, helping them ...
MIT Media Lab Spring Meeting 2022: E14 Startups
During the 2022 Spring Meeting, the following startups affiliated with the Media Lab will be presenting (hosted by the E14 Fund):
https://www.ketryx.com/blog/mit-media-lab-spring-meeting-2022-e14-startups
Modernizing the Medical Device Factory to Work With Software
Medical device manufacturers have mastered the hardware factory — a systematic approach to building devices such as insulin pumps and pacemakers with a focus on quality, safety, and efficiency. How...
https://www.ketryx.com/blog/modernizing-the-medical-device-factory-to-work-with-software
Navigating the FDA's New Draft Guidance on AI-Enabled Devices
The FDA's new draft guidance on AI-enabled devices offers a framework for medical device manufacturers seeking to pursue AI/ML innovation while staying compliant. The draft guidance provides firm d...
https://www.ketryx.com/blog/navigating-the-fdas-new-draft-guidance-on-ai-enabled-devices
PATCH Act: How to Comply in 2023 & Beyond
H.R. 7084, also known as the “PATCH Act of 2022,” outlines a framework for minimal cybersecurity focus within medical devices. The Patch Act (Protecting and Transforming Healthcare Act) has been in...
https://www.ketryx.com/blog/patch-act-how-to-comply-in-2023-beyond
FDA Predetermined Change Control Plan (PCCP): Compliance Guide
In April of 2023, the FDA published the draft guidance “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Dev...
Should You Change Your Process Before You Update Your Tooling?
Many companies are actively improving or developing a plan to improve their quality management system (QMS) procedures. This is a good thing on the surface; however, these businesses often don’t re...
Q&A: The facts about the PATCH Act
This article originally appeared in Medical Design and Outsourcing News on September 4, 2024.
https://www.ketryx.com/blog/q-a-the-facts-about-the-patch-act
Recalls Are Rising. Panic Doesn’t Have To.
FDA recalls are not rare, black-swan events. They are an ongoing operational reality. As a former FDA regulator, I’m convinced that the recall is rarely the most damaging part. The real cost comes ...
https://www.ketryx.com/blog/recalls-are-rising-panic-doesnt-have-to
Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx
The eSTAR program, which stands for Electronic Submission, Tracking, and Reporting, initially focuses on the 510(k) pathway for medical device clearance, including software-based devices. Tradition...
https://www.ketryx.com/blog/simplifying-510k-submissions-with-fdas-estar-program-and-ketryx
Solving the Systems Interconnectivity Problem
This article originally appeared in MD+DI on June 1, 2023.
https://www.ketryx.com/blog/solving-the-systems-interconnectivity-problem-2
Spreadsheet Errors: The Hidden Risk In MedTech
This article originally appeared in Forbes News on January 28, 2024.
https://www.ketryx.com/blog/spreadsheet-errors-the-hidden-risk-in-medtech
StartUp Health Insights: GI Robotics Company Closes $42M
This article originally appeared in Medium News on December 5, 2023.
StartUPDATES: New developments from healthcare startups
Ketryx raised $14 million in Series A funds. The startups sells a platform — designed around FDA regulations and quality standards — that automates much of the work required from medical device com...
https://www.ketryx.com/blog/startupdates-new-developments-from-healthcare-startups
From Vision to Validation: The Story Behind Ketryx's Journey to Transforming MedTech Software
When people think about medical devices, they often imagine physical hardware that administers insulin or keeps their hearts beating at a regular pace. But, as with many things in the 21st century,...
The Best RTM Tools for Agile Teams: Looking Beyond Excel
In the software as a medical device (SaMD) industry, ensuring compliance with regulatory requirements is paramount. One critical aspect of this work is the maintenance of a robust and accurate Requ...
https://www.ketryx.com/blog/the-best-rtm-tools-for-agile-teams-looking-beyond-excel
The Future of Healthcare Is Connected & Data-Driven
This article originally appeared in MD+DI on November 30, 2022.
https://www.ketryx.com/blog/the-future-of-healthcare-is-connected-data-driven
The latest (June 2023) changes to the FDA’s new premarket submission guidance
On June 14, 2023, a long-awaited new FDA guidance Content of Premarket Submissions for Device Software Functions replaced the 2005 version which defined the content of software submissions. This gu...
The Spotify layoff letter, a new AI model from Alibaba, and a Boston VC firm abruptly shuts down
This article originally appeared in StrictlyVC News on December 6, 2024.
The Transformative Impact of Patient Apps in Healthcare
This article originally appeared in Healthtech Build News on August 9, 2021.
https://www.ketryx.com/blog/the-transformative-impact-of-patient-apps-in-healthcare
The Turtle Problem
At Ketryx, we talk to a lot of companies that build medical devices and GxP software. Often, we encounter organizations that have fallen into the trap of doing their own validation for their develo...
The Ultimate Guide to Requirements Traceability Matrix (RTM)
Traceability refers to the ability to track and follow the lineage, history, or relationships of various entities or components within a system or process, which includes establishing and maintaini...
https://www.ketryx.com/blog/the-ultimate-guide-to-requirements-traceability-matrix-rtm
The VentureFizz Podcast with Erez Kaminski
The VentureFizz Podcast Episode 395: Erez Kaminski - CEO & Founder, Ketryx Share
https://www.ketryx.com/blog/the-venturefizz-podcast-with-erez-kaminski
Three steps for traceability in medical device software development quality and compliance
This article originally appeared in Medical Design and Outsourcing News on September 7, 2024.
Three strategies for unlocking the power of continuous integration/continuous deployment (CI/CD) for AI-powered medical devices
This article originally appeared in Medical Design and Outsourcing on November 12, 2024.
Top of the Morning
🚑 Ketryx, a Boston-based provider of lifecycle management software for life sciences, raised $14m in Series A funding. Lightspeed Venture Partners led, and was joined by insiders MIT E14 Fund, and...
Transforming Lifecycle Management
Axendia was recently briefed by Erez Kaminski, founder and CEO of Ketryx. After leading AI initiatives at Amgen, Kaminski saw firsthand how legacy systems hindered innovation. He founded Ketr...
https://www.ketryx.com/blog/transforming-lifecycle-management
UL Certification: A Launchpad for Product Development Excellence
This article originally appeared in Medcity News on June 14, 2024.
https://www.ketryx.com/blog/ul-certification-a-launchpad-for-product-development-excellence
Understanding FDA Guidance on AI in Medical Devices and Predetermined Change Control Plans (PCCPs)
The integration of Artificial Intelligence (AI) into healthcare, particularly within medical devices, has the potential to revolutionize patient care, diagnosis, and treatment. However, the dynamic...
Understanding Software as a Medical Device (SaMD)
The rapid integration of technology into healthcare has opened the doors to groundbreaking innovations, with Software as a Medical Device (SaMD) at the forefront. SaMD stands apart from traditional...
https://www.ketryx.com/blog/understanding-software-as-a-medical-device-samd
Use of AI in imaging paves the way for other medical devices
The FDA approved the first AI-enabled medical device in 1995 for radiology.Three decades later, AI is expanding beyond hospital imaging into technologiesthat can diagnose neurological conditions us...
https://www.ketryx.com/blog/use-of-ai-in-imaging-paves-the-way-for-other-medical-devices
Watch how Ketryx applies AI to automate compliance in regulated software
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https://www.ketryx.com/blog/watch-how-ketryx-applies-ai-to-automate-compliance-in-regulated-software
We Put Our Own QMS Under the Microscope. Here’s What We Found.
We build Ketryx using Ketryx, and we hold ourselves (and are UL certified) to IEC 62304, ISO 13485, and ISO 14971. We do this not only to model compliance, but to prove that modern medical-grade so...
https://www.ketryx.com/blog/we-put-our-own-qms-under-the-microscope-heres-what-we-found
SOUP Software Definition and a Guide to Software Regulations of Unknown Provenance
SOUP, or Software of Unknown Provenance, is any piece of software used in a medical device that wasn’t developed for use in a medical device (i.e. under 62304) or for which such documentation does...
What Makes a Company Successful at Using AI?
This article originally appeared in Harvard Business Review on February 28, 2022.
https://www.ketryx.com/blog/what-makes-a-company-successful-at-using-ai
Who pays the bills when AI kills?
This article originally appeared in The Hill on July 20, 2023.
https://www.ketryx.com/blog/who-pays-the-bills-when-ai-kills
Why So Many Medical Device Companies Lack Real-Time Traceability and Visibility
How long would it take a stakeholder at your company to identify and understand the new and changed requirements in your current product version compared to the previous one? If the answer is anyth...
Why The Epidemic In Quality Failures And What MedTechs Can Learn
This article originally appeared in Forbes on November 8, 2024.
https://www.ketryx.com/blog/why-the-epidemic-in-quality-failures-and-what-medtechs-can-learn
Why the FDA’s Most Common Warning Letter Might Surprise You
The FDA (Food and Drug Administration) is responsible for ensuring the safety and effectiveness of food, drugs, and medical devices in the United States. The agency carries out this mission by...
https://www.ketryx.com/blog/why-the-fdas-most-common-warning-letter-might-surprise-you
Why Validated DevOps is the Path Forward for Regulated Software
This article originally appeared in DevOps.com on January 30, 2025.
https://www.ketryx.com/blog/why-validated-devops-is-the-path-forward-for-regulated-software
Work Smarter: Ketryx’s Native Google Drive Integration
For teams managing quality and design documents, updating files has long been a tedious process: download, edit, save, and re-upload. This cycle slows collaboration, increases the risk of errors, a...
https://www.ketryx.com/blog/work-smarter-ketryxs-native-google-drive-integration
Medical Device Software Development Life Cycle (SDLC) Documentation - Ketryx
Documentation is killing us. It takes time away from our developers coding. ...
Medical Device Quality Management System (QMS) Software - Ketryx
I’ve been looking for this tool all my life! Senior Director of Agile Transformation ...
Medical Device Electronic Quality Management System (eQMS) - Ketryx
Traditional eQMS tools can be overwhelming, complex, and costly, creating bottlenecks in quality processes. Teams struggle with fragmented training management, cumbersome document approvals, and ma...
Medical Device Software Integration Tool - Ketryx
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Medical Device Requirements Management Software - Ketryx
Without an easy way to manage and trace requirements, teams are forced to copy and paste from Jira or Git into another system, like an eQMS or ALM. This wastes valuable developer time and increases...
Medical Device Risk Management Software - Ketryx
Managing risks effectively can be a daunting task with the constant need to ensure comprehensive documentation, adhere to regulatory standards, and track risk controls. Without a robust system in p...
Medical Device Software Bill of Materials (SBOM) Management Software | SBOM Tool Software - Ketryx
Transform your SBOM into an FDA-compliant SBOM. Ketryx enables teams to generate precise, comprehensive SBOMs in minutes through scanning or SPDX import. See current software configurations, get de...
https://www.ketryx.com/capabilities/sbom-software-bill-of-materials
Medical Device Traceability Software - Ketryx
Both R&D and Quality teams say traceability is hard. It’s an interconnected maze spanning tools, people, document types, and versions.
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How Aignostics is Accelerating AI Development in Medicine with Ketryx - Ketryx
Aignostics is a global artificial intelligence (AI) company that turns complex multi-modal pathology data into transformative insights. With an expanding portfolio of AI-powered pathology products,...
How a Top 5 MedTech Company Assessed Vulnerabilities 80% Faster - Ketryx
A top 5 MedTech Surgical Robotics company partnered with Ketryx to modernize its cybersecurity risk assessment process and accelerate vulnerability assessments. After improving their Cybersecurity ...
https://www.ketryx.com/case-studies/assess-vulnerabilities-faster
How Beacon Biosignals Reduced Their Release Cycle to Two Weeks for AI/ML Products with PCCPs - Ketryx
Beacon Biosignals is a pioneer in the FDA’s latest guidance around machine learning and AI in medical devices. In 2024, Beacon received two of the FDA’s 44 total Predetermined Change Control Plan (...
How a Medical Diagnostics Leader Reduced Change Impact Assessment from Days to Minutes with Ketryx AI - Ketryx
An innovative AI-driven diagnostics company uses Ketryx’s AI-native compliance platform to generate hardware and software change impact assessments in minutes—a task that took up to 15 FTE days per...
Ketryx Announces DeepHealth Selected Its Software to Accelerate AI-Powered Health Informatics Innovation - Ketryx
CAMBRIDGE, Mass. - December 4, 2024 - Ketryx announced today that DeepHealth, Inc., a global leader in AI-powered health informatics and a wholly-owned subsidiary of RadNet, Inc. (Nasdaq: RDN...
How Flo Transitioned from Unregulated to Regulated Development—Without Losing Speed - Ketryx
Flo Health is the world’s leading women’s health platform with 430 million users, 77 million monthly active users, and a 200+ person engineering team. The company set out to deliver more clinically...
How Foresight Diagnostics Reduced Documentation Time by 80% - Ketryx
Foresight Diagnostics is a biotechnology company developing advanced diagnostic tools for detecting minimal residual disease (MRD) in cancer patients. The company leverages cutting-edge genomic and...
https://www.ketryx.com/case-studies/foresight-diagnostics-case-study
How Heartflow Reduced Complexity by 90% in 10 Weeks with a System of Systems - Ketryx
HeartFlow is a pioneering SaMD company transforming the diagnosis and treatment of cardiovascular disease with its non-invasive, AI-enabled cardiac test used in conjunction with standard CT scans. ...
How Meta Reality Labs Accelerates Product Innovation with AI - Ketryx
Meta Reality Labs, Meta’s hardware and AI division, partnered with Ketryx to build a lifecycle intelligence system to support compliance and quality management system from the ground up as it enter...
https://www.ketryx.com/case-studies/how-meta-reality-labs-accelerates-safe-innovation-with-ai
How This AI-Powered Medical Software Company Reduced SBOM Documentation Time by 90% - Ketryx
Nutrino Health, a Medtronic company, was looking for a way to manage thousands of components in their AI-powered nutrition platform across the software supply chain, including open-source software,...
How Oui Therapeutics Unified and Accelerated Their SDLC - Ketryx
Oui Therapeutics is dedicated to developing digital therapeutics to save lives, with a particular focus on combating suicide and addressing complex healthcare challenges. Oui’s mission revolves aro...
How Vektor Medical Accelerated Documentation Time by Over 60% with Ketryx - Ketryx
Vektor Medical is a MedTech innovator specializing in AI-powered solutions for cardiac care. The company focuses on developing groundbreaking software that provides actionable insights physicians c...
https://www.ketryx.com/case-studies/vektor-medical-case-study
Boston RAPS Chapter In Person Event: Navigating Evolving Global Requirements to Strengthen Regulatory Readiness Worldwide
Join leading regulatory affairs professionals for an in-depth discussion on navigating evolving global requirements. This panel features experts from Ketryx, LexisNexis Reed Tech, and Dräger, who w...
Life Sciences AI on Tap: Connect with Boston’s Life Sciences Community
One Main Street, 1st Floor, Cambridge, MA 02142
Scaling AI Responsibly: Transforming MedTech and Life Sciences with Validated AI
Location details will be provided upon approved registration
https://www.ketryx.com/events/scaling-ai-responsibly-fireside-chat
Unburdening Builders: Reinventing Regulated Development with AI
Use Cases
https://www.ketryx.com/events/unburdening-builders-reinventing-regulated-development-with-ai
Validated AI Conference
The Engine by MIT | 750 Main St, Cambridge, MA 02139
AI/ML - Ketryx
Change control is disconnected from development workflows and validation workflows are manual and error-prone. You’re making model updates frequently, and doing manual change management—plus making...
Medical Device Software Development FDA Process Compliance - Ketryx
The burden of highly manual release documentation can delay software releases, impacting the ability to quickly bring products to market and losing a competitive edge.
Medical Device Quality Assurance & Regulatory Affairs (QA/RA) Software - Ketryx
Ensuring patient safety, preventing software errors, preparing for audits, and maintaining up-to-date documentation – all while managing risks across the SDLC – is daunting. New regulatory requirem...
Systems Engineering - Ketryx
Maintaining traceability across requirements, design, risk, and verification is overwhelming, especially with traditional tools like spreadsheets. Fragmented ALM, PLM, risk, and testing tools leave...
AI San Diego Meetup - Ketryx
Connect with life sciences innovators and learn how to validate AI faster so you can bring life-changing technology to patients sooner.
Validated AI Conference - Ketryx
Connect with life sciences innovators and learn how to validate AI faster so you can bring life-changing technology to market sooner.
Imprint
Imprint Company name Ketryx Corporation Boston office Ketryx Corporation1 Main St, Suite 510Cambridge, MA 02142 Vienna office Ketryx CorporationWebgasse 43c/o Brains and Bodies1060 ViennaAustriaUID n
Ketryx for Aerospace — AI-Powered DO-178C Compliance
As your engineers write requirements in Jira, push code to GitHub, and run tests in TestRail, Ketryx generates the complete artifact package — Software Requirements Specification, bidirectional tra...
Ketryx for Automotive — AI-Powered ISO 26262 Compliance
HARA safety requirements must be traceable to software units, tests, and back. Ketryx automatically creates and maintains that traceability chain across Jira, Git, and TestRail in real time. No mor...
Defense — AI-Powered CMMC Compliance
As your engineers write requirements in Jira, push code to GitHub, and run tests in TestRail, Ketryx generates contract deliverables — SRS, SDD, STR, test reports — aligned to DID formats automatic...
Medical Devices — AI-powered lifecycle management for life science teams
As your engineers write requirements in Jira, push code to GitHub, and execute tests in TestRail, Ketryx generates your DHF deliverables — software requirements specifications, architecture documen...
Ketryx for Nuclear Energy — AI-Powered IEC 61513 Compliance
As your engineers write requirements in Jira, push code to GitHub, and run tests, Ketryx generates the complete documentation package — Software Requirements Specification, traceability matrices, t...
Robotics — AI-Powered IEC 61508 Compliance
Safety requirements must be traceable from hazard analysis through safety goals, safety requirements, implementation, and verification evidence. Ketryx automatically creates and maintains that trac...
Jama Vs. Ketryx - Ketryx Compliance Framework
Requirements Management Manage requirements individually or as a group using the development tools you know best.
Ketryx Events - Ketryx
Conference Validated AI Conference Location: Cambridge, MA Date: April 9, 2026 Learn more Learn more Upcoming Events Past Event Recordings Networking Life Sciences AI on Tap: Connect with Boston’s Lif
62304-Compliant Traceability for Automated Testing - Ketryx Compliance Framework
Click for sound59:24 This webinar, designed for medical device R&D and quality teams, focuses on achieving seam...
https://www.ketryx.com/learn/webinars/on-demand/62304-compliant-traceability-for-automated-testing
ADO for IEC 62304 and AI: Developing FDA-Compliant Software in Azure DevOps - Ketryx Compliance Framework
Click for sound58:07 This webinar explores how to adapt ADO for IEC 62304 compliance, automating traceability, risk...
ADO for IEC 62304 and AI: Developing FDA-Compliant Software in Azure DevOps - Ketryx Compliance Framework
Click for sound58:07 This webinar explores how to adapt ADO for IEC 62304 compliance, automating traceability, risk...
Breaking the Change Impact Assessment Bottleneck with AI - Ketryx Compliance Framework
Click for sound57:00 Change impact assessment is table stakes for regulatory compliance, yet is one of the biggest ...
Building an Audit-Ready Secure SDLC - Ketryx Compliance Framework
Click for sound52:03 As medical devices become more complex—incorporating AI and increased connectivity—ensuring co...
https://www.ketryx.com/learn/webinars/on-demand/building-an-audit-ready-secure-sdlc
Empowering the SDLC Process with Tools to Bridge R&D and Quality - Ketryx Compliance Framework
Click for sound57:57 This session is designed to bridge the gap between QA/RA professionals and software developers...
FDA Cyber Guidance: Implications for SOUP and OTS Risk Management - Ketryx Compliance Framework
Click for sound50:19 This browser does not support HTML video. ...
FDA-Grade AI: Total Product Lifecycle Control with a PCCP - Ketryx Compliance Framework
Click for sound1:00:11 In this webinar, you will learn how AI/ML is reshaping medical devices and learn practical s...
Git for IEC 62304: Traceability for Software Design, Unit Testing & Requirements - Ketryx Compliance Framework
Click for sound57:55 In this re-broadcast of one of our most popular webinars, you will learn how teams use GitHub ...
https://www.ketryx.com/learn/webinars/on-demand/git-for-62304-jan-26
Git for IEC 62304 - Ketryx Compliance Framework
Click for sound55:59 This session provides an in-depth understanding of how GitHub and GitLab can be leveraged to m...
https://www.ketryx.com/learn/webinars/on-demand/git-for-iec-62304
Git for IEC 62304: Traceability for software design, unit testing, and requirements - Ketryx Compliance Framework
Click for sound1:15:59 This browser does not support HTML video. ...
Git for IEC 62304: Traceability for Software Design, Unit Testing & Requirements - Ketryx Compliance Framework
Click for sound59:39 In this re-broadcast of one of our most popular webinars, you'll gain an in-depth understandin...
How Flo Is Building Regulatory Readiness, Fast - Ketryx Compliance Framework
Click for sound58:45 With over 420M downloads and 68M active users, Flo Health exemplifies how digital health compa...
https://www.ketryx.com/learn/webinars/on-demand/how-flo-is-building-regulatory-readiness-fast
How Meta Preserves a Best-in-Class Engineering Culture in a Regulated Environment - Ketryx Compliance Framework
Click for sound1:18:21 When Meta’s Reality Labs set out to bring AI-enabled smart glasses to market, the goal was c...
How to Make Jira Work for IEC 62304 Development - Ketryx Compliance Framework
Click for sound58:24 Explore how to structure Jira to meet IEC 62304 requirements. This webinar will review each of...
https://www.ketryx.com/learn/webinars/on-demand/how-to-make-jira-work-for-iec-62304-development
How to Use Agentic AI to Systematically Prevent Deviations - Ketryx Compliance Framework
Click for sound58:07 Artificial intelligence (AI) is already writing code, generating requirements, and suggesting ...
How to Use AI Agents in Safety Critical Industries - Ketryx Compliance Framework
Click for sound53:32 Regulated software teams are spending far too much time on manual compliance tasks, slowing do...
https://www.ketryx.com/learn/webinars/on-demand/how-to-use-ai-agents-in-safety-critical-industries
Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices - Ketryx Compliance Framework
Click for sound52:10●●●●●●●●●●●●●●●●●●●●●Understanding PCCP in a CICD EnvironmentOverview of Predetermined Change Control Plans (PCCP)IEC 62304 and Software Lifecycle ManagementChallenges in AI Sof...
Jira for IEC 62304: Developing FDA-Compliant Software - Ketryx Compliance Framework
Click for sound1:02:55 Agile moves fast, but Jira alone wasn’t built to meet the regulatory rigor required for medi...
https://www.ketryx.com/learn/webinars/on-demand/jira-for-62304-jan-26
Jira for 62304: July 31, 2025 - Ketryx Compliance Framework
Click for sound58:24 Explore how to structure Jira to meet IEC 62304 requirements. This webinar will review each of...
https://www.ketryx.com/learn/webinars/on-demand/jira-for-62304-july-2025
Jira for IEC 62304: Developing FDA-Compliant Software - Ketryx Compliance Framework
Click for sound1:01:09 Explore how to structure Jira to meet IEC 62304 requirements. This webinar will review each ...
https://www.ketryx.com/learn/webinars/on-demand/jira-for-iec-62304-2024-10-03
Jira for IEC 62304 Continued - Ketryx Compliance Framework
Click for sound32:45 Due to a large amount of questions and follow-ups from the previous webinar on Jira for IEC 62...
https://www.ketryx.com/learn/webinars/on-demand/jira-for-iec-62304-continued
Jira for IEC 62304: Developing FDA-compliant software - Ketryx Compliance Framework
Free Webinars Jira for IEC 62304: Developing FDA-compliant software February 29, 2024 • 60 minutes Webinar -Jira for IEC 62304 - full recording -22924 Click for sound1:11:07 This browser does not supp
https://www.ketryx.com/learn/webinars/on-demand/jira-for-iec-62304-developing-fda-compliant-software
Jira for regulated development: Making Jira fit for IEC 62304 - Ketryx Compliance Framework
Click for sound38:06 This webinar session covered Jira validation practices and what to consider when using Jira to...
Navigating the FDA’s Total Product Lifecycle Framework for Generative AI Devices - Ketryx Compliance Framework
Click for sound57:31 In this in-depth webinar on Navigating the FDA's Total Product Lifecycle Framework for Generat...
New FDA SOUP/OTS Guidance: Managing Risk and Testing at Scale - Ketryx Compliance Framework
Click for sound38:37 This browser does not support HTML video. ...
Paving the Way for Continuous Innovation: Navigating FDA PCCP Authorization for AI-Driven Medical Devices with Beacon Biosignals - Ketryx Compliance Framework
Click for sound54:26 Beacon Biosignals is a pioneer in the FDA’s latest guidance around machine learning and AI in ...
Postmarket Surveillance of AI Systems: Proactive methods for identifying risk and improving product quality - Ketryx Compliance Framework
Click for sound42:45 This browser does not support HTML video. ...
Product Spotlight Webinar - Google Drive as a Governed Part of Your eQMS - Ketryx Compliance Framework
Click for sound30:43 Many teams rely on Google Drive to draft QMS procedures and DHF documentation, but most eQMS a...
Jira for IEC 62304: Developing FDA-Compliant Software - Ketryx Compliance Framework
Click for sound1:01:27 In this re-broadcast of our most popular webinar, you will learn how to structure Jira to me...
SBOM and Beyond: FDA-Compliant Cybersecurity Vulnerability Management - Ketryx Compliance Framework
Click for sound54:06 Given the growing number of cybersecurity threats, it's crucial for medical device manufacture...
SBOM & Beyond - Ketryx Compliance Framework
Click for sound49:58 In this webinar, you'll learn the techniques to identify cybersecurity vulnerabilities within ...
Simplifying 62304 and AI Compliance with Jira & Polarion - Ketryx Compliance Framework
Click for sound50:24 Software teams building AI-enabled medical devices rely on Jira for development and Polarion f...
Solving the Agile Dilemma: Speed and Safety for AI/ML-Enabled Medical Devices - Ketryx Compliance Framework
Click for sound54:38 An agile approach promises speed, flexibility, and continuous improvement but regulated device...
Streamlining Multi-Region Submissions: Orchestrating MDR, FDA, and EU AI Act Documentation for AI-Enabled Devices - Ketryx Compliance Framework
Click for sound56:24 Bringing AI-enabled medical devices to market means meeting overlapping FDA, EU MDR, and EU AI...
https://www.ketryx.com/learn/webinars/on-demand/streamlining-multi-region-submissions
The Future of Change Management for Cloud-Based AI/ML Medical Software - Ketryx Compliance Framework
Free Webinars The Future of Change Management for Cloud-Based AI/ML Medical Software October 25, 2023 • 60 minutes This browser does not support HTML video. Click for sound37:28 Webinar Resources for
Transitioning from Monolithic to Microservices: How to Adopt a Systems of Systems Approach for Your SDLC - Ketryx Compliance Framework
Click for sound47:44 In this in-depth webinar on how MedTech companies can transition from monolithic software arch...
Transitioning to FDA’s New Premarket Submission Guidance - Ketryx Compliance Framework
Click for sound32:51 This browser does not support HTML video. ...
Understanding the FDA's New Draft Guidance on AI-Enabled Devices - Ketryx Compliance Framework
Click for sound49:37 In this webinar, you will learn about the FDA’s January 2025 draft guidance and its impact on ...
Using a risk-based approach to comply with 21 CFR Part 11 - Ketryx Compliance Framework
Free Webinars Using a risk-based approach to comply with 21 CFR Part 11 October 11, 2023 • 60 minutes This browser does not support HTML video. Click for sound47:31 Webinar Resources for complying wit
Validating AI & LLMs in GxP Use Cases - Ketryx Compliance Framework
Click for sound50:53 AI is already reshaping personalized medicine, clinical trials, pharmacovigilance, and manufac...
https://www.ketryx.com/learn/webinars/on-demand/validating-ai-llms-in-gxp-use-cases
Validating AI & LLMs in GxP Use Cases for Pharma - Ketryx Compliance Framework
Click for sound54:49 AI is already reshaping personalized medicine, clinical trials, pharmacovigilance, and manufac...
https://www.ketryx.com/learn/webinars/on-demand/validating-ai-llms-in-gxp-use-cases-for-pharma
Watch a Demo of Ketryx - Ketryx Compliance Framework
Click for sound10:22●●●●●●●●IntroductionKetryxOverview of the PlatformUnderstanding the VDemo IntroductionNavigating the Software Development Life CycleTraceability and Approval ProcessFinalizing t...
https://www.ketryx.com/learn/webinars/on-demand/watch-a-demo-of-ketryx
Why building AI/ML-enabled Medical Devices requires CI/CD: A transition path - Ketryx Compliance Framework
Free Webinars Why building AI/ML-enabled Medical Devices requires CI/CD: A transition path March 20, 2024 • 60 minutes Webinar Transition to CICD 03182024 Click for sound55:59 This browser does not su
Webinars - 62304-Compliant Traceability for Automated Testing - Ketryx Compliance Framework
This webinar, designed for medical device R&D and quality teams, focuses on achieving seamless documentation and traceability for automated tests in compliance with IEC 62304 standards. Discove...
https://www.ketryx.com/learn/webinars/register/62304-compliant-traceability-for-automated-testing
Webinars - ADO for IEC 62304 and AI: Developing FDA-Compliant Software in Azure DevOps - Ketryx Compliance Framework
Azure DevOps (ADO) is a powerful tool for managing software development, but for medical device manufacturers looking to ensure compliance with IEC 62304—especially when integrating AI—it poses uni...
Webinars - Breaking the Change Impact Assessment Bottleneck with AI - Ketryx Compliance Framework
Change impact assessment is table stakes for regulatory compliance, yet is one of the biggest bottlenecks. Manual, document-driven reviews push CIA cycles into weeks or months, delaying releases an...
https://www.ketryx.com/learn/webinars/register/breaking-the-change-impact-assessment-bottleneck
Webinars - Building an Audit-Ready Secure SDLC: Traceability Across Cybersecurity Risks & Vulnerabilities - Ketryx Compliance Framework
As medical devices become more complex—incorporating AI and increased connectivity—ensuring compliance with FDA and EU MDR requirements is more challenging than ever. Teams responsible for making s...
https://www.ketryx.com/learn/webinars/register/building-an-audit-ready-secure-sdlc
Webinars - Empowering the SDLC Process with Tools to Bridge R&D and Quality - Ketryx Compliance Framework
This session is designed to bridge the gap between QA/RA professionals and software developers, fostering a collaborative environment through improved understanding, processes, and tools.
https://www.ketryx.com/learn/webinars/register/empowering-sdlc-process-tools-bridge-rd-quality
Webinars - FDA Cyber Guidance: Implications for SOUP and OTS Risk Management - Ketryx Compliance Framework
In this live webinar, we will delve into the implications of the new FDA Cybersecurity Guidance on the risk management of SOUP and OTS, with a focus on open-source software. We will cover best prac...
Webinars - FDA-Grade AI: Total Product Lifecycle Control with a PCCP - Ketryx Compliance Framework
Discover how AI/ML is reshaping medical devices and learn practical strategies to navigate the evolving regulatory landscape. In this webinar, former AI leaders from Medtronic and Amgen will share ...
Webinars - Git for IEC 62304: Traceability for Software Design, Unit Testing & Requirements - Ketryx Compliance Framework
This session is designed to provide an in-depth understanding of how GitHub and GitLab can be leveraged to meet the stringent requirements of the IEC 62304. Participants will learn practical strate...
https://www.ketryx.com/learn/webinars/register/git-for-iec-62304-2024-10-31
Webinars - Git for IEC 62304: Traceability for Software Design, Unit Testing & Requirements - Ketryx Compliance Framework
In this re-broadcast of one of our most popular webinars, you will learn how teams use GitHub and GitLab to meet IEC 62304 requirements without slowing development. We will walk through practical w...
https://www.ketryx.com/learn/webinars/register/git-for-iec-62304-jan-25
Webinars - Git for IEC 62304: Traceability for Software Design, Unit Testing & Requirements - Ketryx Compliance Framework
This session is designed to provide an in-depth understanding of how GitHub and GitLab can be leveraged to meet the stringent requirements of the IEC 62304. Participants will learn practical strate...
Webinars - Git for IEC 62304: Traceability for Software Design, Unit Testing & Requirements - Ketryx Compliance Framework
In this re-broadcast of one of our most popular webinars, you'll gain an in-depth understanding of how GitHub and GitLab can be leveraged to meet the stringent requirements of the IEC 62304. Partic...
Webinars - How Flo Is Building Regulatory Readiness for Its AI-Enabled Digital Health App, Fast - Ketryx Compliance Framework
With over 420M downloads and 68M active users, Flo Health exemplifies how digital health companies can scale innovation with confidence by investing early in compliance. Join Roman Bugaev (CTO), Ts...
Webinars - How Meta Preserves a Best-in-Class Engineering Culture in a Regulated Environment - Ketryx Compliance Framework
When Meta’s Reality Labs set out to bring AI-enabled smart glasses to market, the goal was clear: preserve its world-class engineering culture while applying medical-grade rigor to the software com...
Webinars - How to Use Agentic AI to Systematically Prevent Deviations - Ketryx Compliance Framework
Artificial intelligence (AI) is already writing code, generating requirements, and suggesting test cases — but how do RA/QA teams maintain oversight when these tools operate inside regulated workfl...
Webinars - How to Use AI Agents in Safety-Critical Industries - Ketryx Compliance Framework
Regulated software teams are spending far too much time on manual compliance tasks, slowing down innovation and delaying product releases. In this webinar session, you will learn how Ketryx’s valid...
https://www.ketryx.com/learn/webinars/register/how-to-use-ai-agents-in-safety-critical-industries
Webinars - How to Validate AI-Enabled, Non-Product Software, Fast - Ketryx Compliance Framework
Quality and regulatory teams are under increasing pressure to use AI to scale their impact and support faster, AI-assisted development. As non-product software is used in regulated environments, th...
https://www.ketryx.com/learn/webinars/register/how-to-validate-ai-enabled-non-product-software
Webinars - Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices - Ketryx Compliance Framework
The FDA's Predetermined Change Control Plan (PCCP) allows medical manufacturers to update their device without repeated approvals. With this regulatory strategy, top medical device companies are in...
Webinars - Jira for IEC 62304: Developing FDA-Compliant Software - Ketryx Compliance Framework
Explore how to structure Jira to meet IEC 62304 requirements. This webinar will review each of the major sections from 62304, reveal the gaps in Jira for fulfilling that section, and provide a set ...
https://www.ketryx.com/learn/webinars/register/jira-for-iec-62304-developing-fda-compliant-software
Webinars - Jira for IEC 62304: Developing FDA-Compliant Software - Ketryx Compliance Framework
Agile moves fast, but Jira alone wasn’t built to meet the regulatory rigor required for medical device software. Under IEC 62304, that gap shows up as broken traceability, last-minute scramble to c...
https://www.ketryx.com/learn/webinars/register/jira-for-iec-62304-jan-25
Webinars - Navigating the FDA’s Total Product Lifecycle Framework for Generative AI Devices - Ketryx Compliance Framework
Generative AI devices hold transformative potential for healthcare, but ensuring their safety and effectiveness demands robust lifecycle management strategies. Building on the FDA’s Total Product L...
Webinars - Paving the Way for Continuous Innovation: Navigating FDA PCCP Authorization for AI-Driven Medical Devices - Ketryx Compliance Framework
Beacon Biosignals is a pioneer in the FDA’s latest guidance around machine learning and AI in medical devices. In 2024, Beacon Biosignals received two of the FDA’s 44 total Predetermined Change Con...
Webinars - Postmarket Surveillance of AI Systems: Proactive methods for identifying risk and improving product quality - Ketryx Compliance Framework
This webinar provides actionable insights on navigating the post-market regulatory landscape and creating a process focused on patient safety for AI-enabled medical devices. It will focus on best p...
Webinars - Product Spotlight Webinar - Google Drive as a Governed Part of Your eQMS - Ketryx Compliance Framework
Many teams rely on Google Drive to draft QMS procedures and DHF documentation, but most eQMS and ALM tools treat cloud documents as external artifacts. That disconnect leads to manual downloads, ve...
Webinars - How Flo Is Building Regulatory Readiness, Fast - Ketryx Compliance Framework
In this rebroadcast of one of our most popular webinars, you will learn how Flo Health, with over 420M downloads and 68M active users, exemplifies how digital health companies can scale innovation ...
https://www.ketryx.com/learn/webinars/register/rerun-how-flo-is-building-regulatory-readiness-fast
Webinars - SBOM and Beyond: FDA-Compliant Cybersecurity Vulnerability Management - Ketryx Compliance Framework
Given the growing number of cybersecurity threats, it's crucial for medical device manufacturers to adopt a holistic approach to secure products across their lifecycle. Join us for an in-depth expl...
Webinars - Simplifying 62304 and AI Compliance with Jira & Polarion - Ketryx Compliance Framework
Software teams building AI-enabled medical devices rely on Jira for development and Polarion for requirements management, but maintaining traceability between the two is often a manual, error-prone...
Webinars - New FDA OTS Guidance: How to Manage Risk and Testing at Scale - Ketryx Compliance Framework
In this session, we will delve into the latest 2023 FDA guidances, with a particular focus on the use of SOUP and off-the-shelf software (OTS) in medical devices and the content of premarket submis...
https://www.ketryx.com/learn/webinars/register/soup-ots-manage-risk-testing-scale
Webinars - Streamlining Multi-Region Submissions: Orchestrating MDR, FDA, and EU AI Act Documentation for AI-Enabled Devices - Ketryx Compliance Framework
Bringing AI-enabled medical devices to market means meeting overlapping FDA, EU MDR, and EU AI Act requirements. The AI Act classifies most medical AI as high-risk, requiring conformity assessment,...
https://www.ketryx.com/learn/webinars/register/streamlining-multi-region-submissions
Webinars - Streamlining Multi-Region Submissions: MDR, FDA, and EU AI Act - Ketryx Compliance Framework
Bringing AI-enabled medical devices to market requires meeting overlapping FDA, EU MDR, and EU AI Act requirements. The AI Act classifies most medical AI as high-risk, introducing expectations for ...
https://www.ketryx.com/learn/webinars/register/streamlining-multi-region-submissions-with-raps
Webinars - Solving the Agile Dilemma: Speed and Safety for AI/ML-Enabled Medical Devices - Ketryx Compliance Framework
An agile approach promises speed, flexibility, and continuous improvement but regulated device development is slowed by lengthy documentation cycles and approvals. In a regulated setting, an agile ...
Webinars - The Future of Change Management for Cloud-based AI/ML Medical Software - Ketryx Compliance Framework
Join us for an online webinar on how to implement AI/ML best practices for change management. This event is designed to bring developers and quality/regulatory professionals the latest insights int...
Webinars - Transitioning from Monolithic to Microservices: How to Adopt a Systems of Systems Approach for Your SDLC - Ketryx Compliance Framework
Join us for an in-depth webinar on how MedTech companies can transition from monolithic software architectures to a systems of systems approach. Discover how to design an architecture that is purpo...
Webinars - Transitioning to FDA’s New Premarket Submission Guidance: Impact on Quality Systems and Development Practices - Ketryx Compliance Framework
On June 14, 2023, FDA released the Content of Premarket Submissions for Device Software Functions replacing the 2005 version, which defined the content of software submissions. The recent update br...
Webinars - Understanding the FDA's New Draft Guidance on AI-Enabled Devices: What MedTech Companies Need to Know - Ketryx Compliance Framework
The FDA’s January 2025 draft guidance on AI-enabled devices is a significant step forward, offering a framework for manufacturers to bring innovative, AI-driven devices to market while maintaining ...
Webinars - Using a risk-based approach to comply with FDA's 21 CFR Part 11 - Ketryx Compliance Framework
Join us for an insightful and comprehensive webinar on how to validate products to 21 CFR Part 11 standard using a risk-based approach (i.e.Computer Software Assurance).
https://www.ketryx.com/learn/webinars/register/using-a-risk-based-approach-to-comply-with-fda
Webinars - Validating AI & LLMs in GxP Use Cases - Ketryx Compliance Framework
AI is already reshaping personalized medicine, clinical trials, pharmacovigilance, and manufacturing, but most teams are stuck trying to validate AI models with legacy tools built for deterministic...
https://www.ketryx.com/learn/webinars/register/validating-ai-llms-in-gxp-use-cases
Webinars - Validating AI & LLMs in GxP Use Cases for Pharma - Ketryx Compliance Framework
AI is already reshaping personalized medicine, clinical trials, pharmacovigilance, and manufacturing—but most pharma and biotech teams are stuck trying to validate AI models with legacy tools built...
https://www.ketryx.com/learn/webinars/register/validating-ai-llms-in-gxp-use-cases-for-pharma
Webinars - Why building AI/ML-enabled Medical Devices requires CI/CD: A transition path - Ketryx Compliance Framework
Watch this recorded webinar where we uncover the essential role of Continuous Integration and Continuous Delivery (CI/CD) in building AI/ML-enabled medical devices and SaMD. Learn why adopting CI/C...
Webinars - Why Resubmit When You Can Ship? How to Accelerate Innovation with PCCPs and CI/CD - Ketryx Compliance Framework
Predetermined Change Control Plans (PCCPs) are quickly becoming a critical tool for medical device teams, enabling manufacturers to pre-authorize defined changes, reduce repeated regulatory submiss...
Medical Device GxP Compliance, Audit & Management Software - Ketryx
March 2026Select a day in MarchSunMonTueWedThuFriSat123456789101112131415161718192021222324252627282930311234567891011Now displaying available times for March 5th.Meeting locationZoomHow long do yo...
Ketryx Announces DeepHealth Selected Its Software to Accelerate AI-Powered Health Informatics Innovation - Ketryx Compliance Framework
CAMBRIDGE, Mass. - December 4, 2024 - Ketryx announced today that DeepHealth, Inc., a global leader in AI-powered health informatics and a wholly-owned subsidiary of RadNet, Inc. (Nasdaq: RDN...
Ketryx Appoints Mary Brook Delano as Chief Business Officer to Accelerate Growth, Sales Execution, and Customer Impact - Ketryx Compliance Framework
Cambridge, Mass. - June 18, 2025 - Ketryx, the leader in AI-powered compliance for life sciences, today announced the appointment of Mary Brook Delano as Chief Business Officer. In this newly creat...
Ketryx Launches First Validated AI Agents to Accelerate Safety-Critical Product Development - Ketryx Compliance Framework
CAMBRIDGE, Mass. – May 1, 2025 – Ketryx, the leader in AI-powered compliance for life sciences, today announced the launch of the first validated AI agents for regulated industries. This industry-f...
Ketryx Marks Milestone Year, Impacting Over 20M+ Patients in MedTech - Ketryx Compliance Framework
New AI Capabilities, Customer Milestones, and Certifications Power Ketryx Forward
Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners - Ketryx Compliance Framework
BOSTON, Mass, December 5, 2023: Ketryx, provider of the first and only connected application lifecycle management software for the life sciences industry, today announced that it has raised $14 Mil...
Ketryx Unveils the First Connected Lifecycle Software for MedTechs - Ketryx Compliance Framework
SOMERVILLE, MA – May 16, 2023 – Ketryx, the creator of the first connected lifecycle management software for MedTechs, today announced new usability and productivity updates to its flagship s...
Ketryx Enters 2026 with Record Momentum as Demand for Validated AI Surges - Ketryx Compliance Framework
CAMBRIDGE, Mass. — February 26, 2026 — Ketryx, the AI-native compliance platform for safety-critical product development, today announced record momentum following a year in which the company...
https://www.ketryx.com/press-release/momentum-as-demand-for-validated-ai-surges
Ketryx Raises $39M Series B Round to Power the Future of Regulated Artificial Intelligence for Life Sciences - Ketryx Compliance Framework
CAMBRIDGE, MA/VIENNA, AUSTRIA — September 4, 2025 — Ketryx, the AI-powered compliance platform helping life sciences companies ship safer products faster, today announced a $39 million Series B led...
Watch On Demand Demo - Ketryx Compliance Framework
Click for sound15:08●●●●●●●●●●●●●●●●●●●●●●●Introduction to the Ketryx PlatformIntegrating Additional ToolsAdding a New FeatureModifying Requirement SpecificationsPeer Review and Approval ProcessRev...
Pricing - Ketryx Compliance Framework
Plans and Pricing Ketryx Pricing for Connected Lifecycle Management Ketryx delivers cutting-edge software for growing teams and enterprises. We support compliance with the latest Life Science regulato
Privacy Policy
Ketryx Corporation (“Ketryx,” “we,” “us,” or “our”) is one of the leading providers of medical device software regulation and quality assurance. This Privacy Policy applies to the personal informat...
The Ketryx FDA Software Compliance Platform - Ketryx
Meet the Ketryx Platform AI-powered lifecycle management for life science teams The only developer-first connected lifecycle management platform built to use your preferred tooling Preview Product 6 S
Schedule a Demo - Ketryx Compliance Framework
Get a custom walkthrough based on your tools See how top MedTech companies are accelerating releases of safer, validated software, with automated traceability and documentation. Orchestrate releases a
FDA Medical Device Software Compliance, Audits, & Validation for Enterprises - Ketryx
By automating the DHF, Ketryx frees teams to focus on building life-saving products rather than chasing down documentation. As a result, Ketryx customers bring more releases to market faster withou...
FDA Medical Device Software Compliance, Audits, & Validation for Startups - Ketryx
Ketryx offers predefined, FDA-ready templates and guidance for IEC 62304, ISO 14971, CFR 21 Part 11 embedded into the software based on input from former FDA talent. Instead of worrying about docum...
Terms of Service
These Terms of Service to the Master Services Agreement to which they are appended govern access to and use of the Ketryx Platform and associated products services by the Customer listed on t...
AI/ML GxP Pharma
Artificial Intelligence Regulatory Compliance AI-Enabled Compliance for GxP Software Simplify change management and accelerate development across your AI lifecycle. For many teams, internal processes
AI/ML IVD Diagnostics
Heartflow, a SaMD company serving 250,000 patients annually, needed to speed up development and release their AI-based software more frequently. By adopting a system of systems approach, Heartflow ...
AI/ML Medical Device Compliance Software - Ketryx
Heartflow, a SaMD company serving 250,000 patients annually, needed to speed up development and release their AI-based software more frequently. By adopting a system of systems approach, Heartflow ...
Change Impact Assessment - Ketryx
Managing change in regulated product development is complex. Even small updates can ripple across requirements, tests, risks, and documentation, making manual Change Impact Assessment slow, inconsi...
Medical Device Component Reuse Software - Ketryx
Heartflow, a SaMD company serving 250,000 patients annually, needed to speed up development and release their AI-based software more frequently. By adopting a system of systems approach, Heartflow ...
🟩 GenAI in Your TPLC
Your teams want to use AI, but you have concerns about safety and accuracy.
Medical Device GxP Compliance, Audit & Management Software - Ketryx
AI for Life Sciences Build risk-based GxP computer systems Reduce the complexity, time, and cost of building GAMP 5 validated applications. Automatically generate user requirements, testing plans, and
FDA, EU MDR, & ISO Medical Device 62304 Compliance Software for Jira - Ketryx
Ketryx ensures seamless traceability, allowing you to track every aspect of your product's lifecycle — from user requirements to specs to tests — while you’re working in Jira.
ISO 26262, ASPICE, and UNECE R156 Automotive Software Compliance for Jira | Ketryx
Ketryx provides continuous, end-to-end safety traceability inside Jira so vehicle teams can understand coverage, change impact, and release readiness across requirements, code, tests, and fielded v...
https://www.ketryx.com/use-case/jira-connector-for-automotive
Multifunction Device
Heartflow, a SaMD company serving 250,000 patients annually, needed to speed up development and release their AI-based software more frequently. By adopting a system of systems approach, Heartflow ...
Software as a Medical Device (SaMD) Lifecycle Management & FDA Compliance Software - Ketryx
SaMD Compliance Software Software as a Medical Device (SaMD) and Connected Devices Reduce the complexity, time, and cost of building Software as a Medical Device (SaMD) applications with the only deve
Medical Device Traceability to Automated Tests Software - Ketryx
When your automated tests live in Git, but your test cases live in Jira, developers are forced to manually document automated test cases to ensure traceability.
https://www.ketryx.com/use-case/traceability-to-automated-tests
Document Generation with Ketryx - Ketryx
Click for sound0:52 Ketryx offers real-time feedback on compliance status, identifies potential issues, and automat...
Enforcement in Jira with Ketryx - Ketryx
Click for sound1:37 Using Jira automation alone adds complexity and additional maintenance. With Ketryx, quality ma...
https://www.ketryx.com/videos/enforcement-in-jira-with-ketryx-video
Item Variant Management: Baseline Locking - Ketryx
Click for sound2:23 Join VP of Client Operations Jake Stowe as he showcases the new locking feature in version 2.10...
https://www.ketryx.com/videos/item-variant-management-baseline-locking
New in 2.11: Enhanced Jira Traceability Widget - Ketryx
Click for sound4:21 Ketryx users can now manage traceability relationships from the Jira traceability widget, expan...
https://www.ketryx.com/videos/jira-traceability-widget-improvements
Introduction to Ketryx - Ketryx
Click for sound15:08●●●●●●●●●●●●●●●●●●●●●●●Introduction to the Ketryx PlatformIntegrating Additional ToolsAdding a New FeatureModifying Requirement SpecificationsPeer Review and Approval ProcessRev...
Ketryx Intelligence - Ketryx
Click for sound10:19 See how Ketryx Intelligence, Ketryx's AI functionality, can transform your work. Discover how ...
Lessons learned from 23 MedTech companies in 2024 - Ketryx
Videos Lessons learned from 23 MedTech companies in 2024 Click for sound1:55 More videos No items found. Are You Building Medical Software? Get started building software in minutes, not months.Book a
https://www.ketryx.com/videos/lessons-learned-from-23-medtech-companies-in-2024
Local Traceability in Jira with Ketryx - Ketryx
Click for sound0:48 By linking requirements, design artifacts, code changes, tests, and risks within Jira, Ketryx e...
https://www.ketryx.com/videos/local-traceability-in-jira-with-ketryx
Managing Requirements with Jira and Ketryx - Ketryx
Click for sound0:23 Ketryx is a pioneering CLM platform with the most advanced software in this category. Its seaml...
https://www.ketryx.com/videos/managing-requirements-jira-ketryx
Part 11-Compliant Audit Trail in Jira with Ketryx - Ketryx
Click for sound1:50 Ketryx creates Part 11-compliant records of all development activities and decisions within Jir...
https://www.ketryx.com/videos/part-11-compliant-audit-trail-video
Part 11-Compliant Signatures in Jira - Ketryx
Click for sound1:47 Ketryx enables Part 11-compliant signatures directly in the Jira interface, enabling seamless a...
https://www.ketryx.com/videos/part-11-compliant-signatures-in-jira
New in 2.11: RTM Configurations - Ketryx
Click for sound1:50 Ketryx users can now maintain multiple RTM configurations and can choose which one they want to...
Performing a Release in Ketryx - Ketryx
Click for sound1:55 Watch as Jan performs an incremental release in Ketryx with the Git integration. Out-of-the-box...
Risk Management in Jira and Ketryx - Ketryx
Click for sound1:42 Ketryx incorporates 62304-compliant risk management functionalities into Jira, enabling continu...
https://www.ketryx.com/videos/risk-management-in-jira-and-ketryx
Scaling AI Responsibly for MedTech and Life Sciences with Validated AI - Ketryx
Videos Scaling AI Responsibly for MedTech and Life Sciences with Validated AI Click for sound1:09:37 More videos No items found. Are You Building Medical Software? Get started building software in min
https://www.ketryx.com/videos/scaling-ai-responsibly-firesidechat
Tracing Manual and Automated Tests across Jira and Connected Systems - Ketryx
Videos Tracing Manual and Automated Tests across Jira and Connected Systems Click for sound1:57 More videos No items found. Are You Building Medical Software? Get started building software in minutes,
https://www.ketryx.com/videos/tracing-manual-and-automated-tests-across-jira-and-connected-systems
Unburdening Builders: Reinventing Regulated Development with AI - Ketryx
Videos Unburdening Builders: Reinventing Regulated Development with AI Click for sound36:25 More videos AI Ketryx Intelligence Are You Building Medical Software? Get started building software in minut
https://www.ketryx.com/videos/unburdening-builders-reinventing-regulated-development-with-ai
A Playbook for Transforming Jira to Support IEC 62304 Compliance White Paper - Ketryx Compliance Framework
Learn how to navigate the challenges of using Jira for regulated medical device software development with this comprehensive guide. This white paper outlines actionable strategies to align Jira wit...
https://www.ketryx.com/white-papers/a-playbook-for-transforming-jira-to-support-iec-62304-compliance
A Guide To Implementing CI/CD in Your AI/ML SaMD Projects White Paper - Ketryx Compliance Framework
The number of AI-powered medical devices is rapidly increasing, with 950 AI/ML-enabled devices already authorized by the FDA. However, the journey to successfully developing and managing these comp...
Discover Why Traceability Doesn't Have to Be So Hard White Paper - Ketryx Compliance Framework
Software is the leading cause of medical device recalls. Heavily regulated products such as safety-critical medical devices require that every step of the development process must be traceabl...
https://www.ketryx.com/white-papers/discover-why-traceability-doesnt-have-to-be-so-hard
FDA Cyber Guidance and the Software Supply Chain: A Playbook for Shifting Left White Paper - Ketryx Compliance Framework
Learn how to navigate the complex landscape of cybersecurity for medical devices with this comprehensive guide. This white paper outlines actionable strategies to address vulnerabilities, manage ri...
FDA PCCP Compliance Guide White Paper - Ketryx Compliance Framework
The FDA's guidance on Predetermined Change Control Plans (PCCPs) aims to streamline regulatory processes for AI/ML-enabled medical devices. The guidance allows manufacturers to make software update...
https://www.ketryx.com/white-papers/fda-pccp-compliance-guide
IDC Spotlight: Connected Life-Cycle Management Streamlines Software Development for Medical Devices White Paper - Ketryx Compliance Framework
As software increasingly becomes a competitive advantage in medical devices, MedTech companies must find ways to accelerate development while staying compliant. This IDC Spotlight Paper explores ho...
IEC 62304 Compliance Checklist White Paper - Ketryx Compliance Framework
Companies can take a few key steps to evaluate quality practices on their FDA compliance journey to build medical software. Use this checklist to manage the key steps.
https://www.ketryx.com/white-papers/iec-62304-compliance-checklist
Inside the FDA Regulatory Process White Paper - Ketryx Compliance Framework
Understanding the background and motivating factors for FDA’s Center for Devices and Radiological Health (CDRH) and the Office of Regulatory Affairs personnel will help you get a better understandi...
https://www.ketryx.com/white-papers/inside-the-fda-regulatory-process
JavaScript Static Analysis Tools for Medical Devices White Paper - Ketryx Compliance Framework
The focus of this paper is on software applications (Apps) written in Javascript that meet the Food and Drug Administration’s (FDA) regulatory definition of a medical device. Because medical device...
https://www.ketryx.com/white-papers/javascript-static-analysis-tools-for-medical-devices
FDA Predetermined Change Control Plan (PCCP) Template White Paper - Ketryx Compliance Framework
This template is designed to assist organizations in developing a comprehensive plan to manage and assess modifications to Machine Learning Device Software Functions (ML-DSFs) in medical devices. T...
QMS Optimization Workshop Template White Paper - Ketryx Compliance Framework
Even well-designed QMS processes accumulate friction over time: extra fields, duplicated information, manual checks, and unclear ownership that slow teams down. This workshop template gives you a s...
https://www.ketryx.com/white-papers/qms-optimization-workshop-template
Regulatory Pathways White Paper - Ketryx Compliance Framework
Learn about the different approval pathways possible, and how to find the one that works best for you.
SaMD Regulatory Requirements White Paper - Ketryx Compliance Framework
Learn which essential regulations and standards are necessary to meet compliance for SaMD and other medical device software.
https://www.ketryx.com/white-papers/samd-regulatory-requirements
The Cost of Quality White Paper - Ketryx Compliance Framework
Quality is the ability of a product to meet its requirements and customer expectations without issue. It’s the foundation of any product, from its development to its introduction to consumers. With...
Modernizing FDA-Grade Software Development with Validated DevOps White Paper - Ketryx Compliance Framework
Delivering compliant software quickly without compromising on quality is a significant challenge. Modern MedTech software development must balance innovation with stringent regulatory compliance. R...
https://www.ketryx.com/white-papers/validated-devops-white-paper
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Ketryx Careers | Medical Device Compliance Careers
Featured Interview Ketryx CEO discusses the future of innovation in the Life Sciences industry Watch the interview Move on What Matters Take the first step. We move fast on what matters most by priori
Ketryx Open Positions - Ketryx
Channel and Strategic Partnerships DirectorBoston, Massachusetts, United StatesView positionSales Operations ManagerBoston, Massachusetts, United StatesView positionEnterprise Account ExecutiveBoston,
Professional Services
Enterprise-Grade Expertise Trusted by top medtech companies. Faster Time to Value Reduce onboarding and migration overhead. Built for Scale Services can expand with product innovation Erez Kaminski CE
Medical Software Development Resources | SaMD Resources for Devs & Executives - Ketryx
QMS Optimization Workshop Template This practical workshop template is designed to guide regulated teams in regular QMS reviews to identify process debt and apply a modern, risk-based, AI-assisted app
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