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Product

[Use Cases](https://www.ketryx.com/#) [Capabilities](https://www.ketryx.com/#) [Function](https://www.ketryx.com/#) [Integrations\\
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[What is Ketryx?\\
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AI-native compliance for regulated medical applications\\
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Read more](https://www.ketryx.com/product)

[Solutions](https://www.ketryx.com/#solutions-tab) [Capabilities](https://www.ketryx.com/#capabilities-tab) [Function](https://www.ketryx.com/#function-tab)

[Solutions](https://www.ketryx.com/#)

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AI/ML in Medical Devices\\
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Rapidly accelerate AI/ML software development and deployment, while staying compliant.](https://www.ketryx.com/use-case/ai-ml-med-device)

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SaMD and Connected Devices\\
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Reduce the complexity, time, and cost of building SaMD (Software as a Medical Device) applications.](https://www.ketryx.com/use-case/samd)

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Jira for 62304\\
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Transform Jira into a validated, compliant platform for medical device development.](https://www.ketryx.com/use-case/jira-connector)

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System of Systems\\
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Accelerate development and reuse components through a system of systems architecture.](https://www.ketryx.com/use-case/component-reuse)

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AI Governance for Life Sciences\\
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Reduce the complexity, time, and cost of GxP validation for your application.](https://www.ketryx.com/use-case/ai-ml-gxp-life-science)

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AI Change Impact Assessment\\
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Apply AI to identify, analyze, and act on change impacts across the DHF with less manual work and greater confidence.](https://www.ketryx.com/use-case/change-impact-assessment)

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Traceability to Automated Tests\\
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Automatically trace automated tests in Git to requirements in Jira.](https://www.ketryx.com/use-case/traceability-to-automated-tests)

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Multifunction Devices\\
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Release device and non-device functions independently with a system of systems architecture.](https://www.ketryx.com/use-case/multifunction-device)

[Watch a short recorded demo](https://www.ketryx.com/on-demand-demo)

[Capabilities](https://www.ketryx.com/#)

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AI Agents\\
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Automate arduous tasks across your toolchain with safety-critical AI agents that keep a human in the loop.](https://www.ketryx.com/capabilities/ai-agents)

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SBOM Management\\
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See a single consolidated view of your open-source supply chain directly from your source code.](https://www.ketryx.com/capabilities/sbom-software-bill-of-materials)

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Traceability\\
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Automatically create a real-time requirements traceability matrix by connecting items, risks, code, and tests from all your systems.](https://www.ketryx.com/capabilities/traceability)

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Documentation\\
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Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF).](https://www.ketryx.com/capabilities/documentation)

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Enforcement\\
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Enforce your QMS to ensure your team is following SOPs exactly as you've defined them.](https://www.ketryx.com/capabilities/enforcement)

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AI SDLC Transformation\\
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Accelerate your AI maturity, guided by our experts](https://www.ketryx.com/capabilities/professional-services)

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Requirements Management\\
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Manage and trace requirements across connected systems like Jira.](https://www.ketryx.com/capabilities/requirements-management)

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Risk Management\\
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Control and document every risk automatically in a 14971-compliant way.](https://www.ketryx.com/capabilities/risk-management)

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eQMS\\
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Navigate compliance confidently with an eQMS that's interoperable with all your favorite tools.](https://www.ketryx.com/capabilities/eqms)

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Physical AI\\
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Build and certify robots, vehicles, and safety-dependent devices with built-in functional safety, traceability, and compliance.](https://www.ketryx.com/physical-ai)

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[Watch a short recorded demo](https://www.ketryx.com/on-demand-demo)

[Function](https://www.ketryx.com/#)

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QA / RA\\
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Enforce your QMS procedures, prevent process deviation, and ensure your software is audit-ready 100% of the time throughout the SDLC.](https://www.ketryx.com/function/quality)

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Dev / R&D\\
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Keep your developers working in their preferred DevTools while maintaining compliance and traceability.](https://www.ketryx.com/function/developer)

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AI/ML Leaders\\
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Reduce your documentation burden by 90% and release your AI products faster.](https://www.ketryx.com/function/ai-ml)

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Systems Engineering\\
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Manage architecture and monitor change impact across the total product lifecycle](https://www.ketryx.com/function/systems-engineering)

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[Watch a short recorded demo](https://www.ketryx.com/on-demand-demo)

[What is Ketryx?\\
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AI-native compliance for regulated medical applications\\
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Read more](https://www.ketryx.com/product)

Use Cases

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Jira for 62304\\
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Transform Jira into a validated, compliant platform for medical device development.](https://www.ketryx.com/use-case/jira-connector)

[Watch a short recorded demo](https://www.ketryx.com/on-demand-demo)

Capabilities

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Enforcement\\
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Enforce your QMS to ensure your team is following SOPs exactly as you've defined them.](https://www.ketryx.com/capabilities/enforcement)

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AI SDLC Transformation\\
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Accelerate your AI maturity, guided by our experts](https://www.ketryx.com/capabilities/professional-services)

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Risk Management\\
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Control and document every risk automatically in a 14971-compliant way.](https://www.ketryx.com/capabilities/risk-management)

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eQMS\\
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Navigate compliance confidently with an eQMS that's interoperable with all your favorite tools.](https://www.ketryx.com/capabilities/eqms)

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[Watch a short recorded demo](https://www.ketryx.com/on-demand-demo)

Function

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AI/ML Leaders\\
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Reduce your documentation burden by 90% and release your AI products faster.](https://www.ketryx.com/function/ai-ml)

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[Watch a short recorded demo](https://www.ketryx.com/on-demand-demo)

[Integrations](https://www.ketryx.com/capabilities/integrations)

Case Studies

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Learn how Meta Reality Labs builds regulated medical products without sacrificing engineering velocity.](https://www.ketryx.com/case-studies/how-meta-reality-labs-accelerates-safe-innovation-with-ai)

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See how Flo Health, with 430M users, transitioned to regulated development in just 90 days](https://www.ketryx.com/case-studies/flo-health)

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Learn how AI-powered radiology company DeepHealth accelerated product development with Ketryx](https://www.ketryx.com/case-studies/deephealth-case-study)

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See how AI-powered nutrition platform Nutrino reduced SBOM documentation time by 90%](https://www.ketryx.com/case-studies/nutrino-case-study)

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Discover how AI/ML-enabled cardiovascular MedTech company HeartFlow reduced complexity by 90% with a system of systems](https://www.ketryx.com/case-studies/heartflow-case-study)

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Learn how an AI-driven diagnostics company transformed change impact assessment](https://www.ketryx.com/case-studies/change-impact-ketryx-ai)

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Learn how Beacon Biosignals reduced their release cycle to two weeks for AI/ML products](https://www.ketryx.com/case-studies/beacon-biosignals)

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Learn how a Top 5 MedTech company assessed vulnerabilities 80% faster](https://www.ketryx.com/case-studies/assess-vulnerabilities-faster)

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Discover how AI pathology company Aignostics stopped copying and pasting and accelerated their release cycle time](https://www.ketryx.com/case-studies/aignostics-case-study)

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Explore how Foresight Diagnostics accelerated their documentation cycle by 5x](https://www.ketryx.com/case-studies/foresight-diagnostics-case-study)

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See how AI-enabled cardiovascular MedTech company Vektor Medical reduced documentation cycle time by 60%](https://www.ketryx.com/case-studies/vektor-medical-case-study)

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See how Oui Therapeutics unified and accelerated their software development lifecycle](https://www.ketryx.com/case-studies/oui-therapeutics)

“Ketryx AI is the most scalable approach we’ve used for regulated product development. It lets our teams make frequent, safe changes while staying continuously audit-ready, without relying on linear headcount growth or stopping teams for compliance exercises.”

Lucas Fernandez

Director of Medical Devices

"Ketryx gave us a scalable way to manage product cybersecurity risk. We’re running assessments more frequently, prioritizing the right issues, and improving our overall security posture without increasing effort."

Director of Product Security

"Delivering quickly is core to our mission because faster releases mean better health outcomes for our users. Ketryx is the only partner we found that gave us the ability to maintain our velocity while achieving medical-grade quality.”

Roman Bugaev

CTO

“We’re excited about how Ketryx helps us improve our overall pace of release. With Ketryx’s AI, we’ve transformed our multi-week manual process of change impact analysis into less than an hour.”

CTO

“The Ketryx software enables us to scale our innovation with quality through a single streamlined software development lifecycle, helping us expedite releases.”

Sham Sokka

Chief Operating and Technology Officer for Digital Health

"Ketryx is becoming an intrinsic part of every piece of software we build. It’s not another tool we have to use on the side to be compliant with standards; it’s just a natural way of developing high-quality software with excellence."

Helmut Hoffer von Ankershoffen

Senior VP Product and Engineering

"Vektor Medical has been through three audits, including one from a leading notified body in 2024. All auditors were amazed by the level of detail, linkage and control that is built into Ketryx. The auditors were especially impressed by the trace matrix dashboard and risk management module. Ketryx is an efficient and compliant solution for medical device software development."

Mihir Naik

Senior Director, Quality

“Ketryx empowered Nutrino to accelerate the adoption of OTS software and SOUP, ensuring confidence in our ability to proactively identify high-risk components and address potential issues early in the premarket submission cycle. This streamlined SDLC process has enabled us to deliver innovative and safe diabetes solutions much more rapidly.”

Chen Weitz

Senior Engineering Director

"I used a traditional ALM in the past and it didn’t have the traceability I needed, especially tracing from my test executions and results. It also created duplicate work since I needed to go update my work there every time I completed a task. Ketryx updates itself as I’m working in Jira and GitHub. This tighter integration into our current tools helps us be more productive and release faster."

Aaron Berlin

SVP Development and Engineering

“Ketryx supports our system of systems architecture really easily out of the box. We were able to migrate our monolithic ecosystem into a single project and break it down into a desired state just within a couple of days. Ketryx delivered that because it was designed to scale. That was a huge plus.”

Emre Gültürk

VP of Regulatory Affairs and Quality Systems

“Ketryx has allowed us to channel our hardware and software engineers’ existing set of development, testing, and documentation practices directly into the generation of compliant documentation with minimal additional burden. This has allowed us to remain agile while delivering high-quality products.”

Alexander Chan

VP of Analytics and Machine Learning

“Overall we’ve been very happy relative to our previous workflow. Ketryx lets us get a lot more granular and more specific in terms of defining the configuration items. It maps much better onto our software development workflow and processes.”

Alec Winograd

VP of Engineering

Industries

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Medical Devices\\
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FDA, MDR, ISO 13485 aligned development](https://www.ketryx.com/industries/medical-devices)

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Robotics\\
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IEC 61508 compliant autonomous systems](https://www.ketryx.com/industries/robotics)

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Automotive\\
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ISO 26262 & ASPICE aligned lifecycles](https://www.ketryx.com/industries/automotive)

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Aerospace\\
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DO-178C, DO-254, ARP4754A assurance](https://www.ketryx.com/industries/aerospace)

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Defense\\
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CMMC, MIL-STD-882E & 498 aligned mission systems](https://www.ketryx.com/industries/defense)

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Nuclear Energy\\
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IEC 61513 & 60880 compliant digital I&C modernization](https://www.ketryx.com/industries/nuclear-energy)

[Pricing](https://www.ketryx.com/pricing)

Resources

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Documentation\\
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Access Ketryx's extensive product documentation.](https://docs.ketryx.com/Nfv9ttHxYK0eaVZFq3wl/)

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Blog\\
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Learn about regulated medical device software development.](https://www.ketryx.com/learn/blog)

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Support and FAQs\\
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Customers submit tickets here for all product needs.](https://ketryx.zendesk.com/hc/en-us)

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Webinars\\
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Hear from experts on medical device software development.](https://www.ketryx.com/learn/webinars)

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In-Person Events \\
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Network with peers in life science and the Ketryx team](https://www.ketryx.com/learn/events)

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White Papers\\
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Take a deep dive into regulated software development.](https://www.ketryx.com/learn/white-papers)

About

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Company\\
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Learn the origin story of Ketryx and how we got to where we are today.](https://www.ketryx.com/about/company)

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Why Ketryx\\
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Understand why regulated software teams choose Ketryx.](https://www.ketryx.com/about/why-ketryx)

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Careers\\
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Learn about our team and opportunities to join us.](https://www.ketryx.com/about/careers)

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Newsroom\\
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See recent press about Ketryx's work with life sciences teams.](https://www.ketryx.com/about/newsroom)

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Certifications\\
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See our compliance with international standards](https://www.ketryx.com/about/certifications)

[Get started](https://app.ketryx.com/auth/signup?callbackUrl=https%3A%2F%2Fapp.ketryx.com)

[Book a demo](https://www.ketryx.com/schedule-demo) [Preview Ketryx](https://www.ketryx.com/on-demand-demo)

[Preview Ketryx](https://www.ketryx.com/on-demand-demo) [Book a Demo](https://www.ketryx.com/schedule-demo)

[Button Text](https://www.ketryx.com/#)

[Try for Free](https://app.ketryx.com/auth/signup?callbackUrl=https%3A%2F%2Fapp.ketryx.com) [](https://www.ketryx.com/#)

[](https://www.ketryx.com/#)

[](https://www.ketryx.com/#)

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# AI for regulated product development.  Safer products, faster.

Ketryx is the AI platform trusted by 4 of the top 5 medical device manufacturers to bridge the gap between development and regulatory compliance. Teams stay in their preferred tools, while Ketryx AI generates traceability and documentation—reducing documentation burden by up to 90%.

Trusted By:

[Preview Product](https://www.ketryx.com/on-demand-demo) [Book a Demo](https://www.ketryx.com/schedule-demo)

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Artboard 1 \| Lottielab

Artboard 1 \| Lottielab

“We are harnessing the power of AI to tackle clinical and operational challenges that arise in complex, high-volume care settings, with the aim of enabling better outcomes. Ketryx enables us to scale our innovation with quality through a single streamlined software development lifecycle, helping us expedite releases.”

**Sham Sokka**

Chief Operating and Technology Officer for Digital Health

0x

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Reduction in documentation time

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Hours saved per engineer per year

AI-Driven Documentation, Real-Time Traceability, Seamless Integration, Agentic AI.

## One Validated Platform, Total Compliance.

Regulated industries have always faced a trade-off: move fast or stay compliant. Ketryx eliminates the choice by seamlessly connecting product development with regulatory requirements. Innovation can finally move at the pace of technology—without sacrificing safety, quality, or compliance.

[Automated Documentation](https://www.ketryx.com/#)

[AI Agents](https://www.ketryx.com/#)

[Traceability](https://www.ketryx.com/#)

[QMS Enforcement](https://www.ketryx.com/#)

[Release Faster](https://www.ketryx.com/#)

Previous

# AI generated compliant documentation as you build.

[Explore AI-Driven Documentation](https://www.ketryx.com/capabilities/documentation)

> Ketryx's ability to generate technical documentation on the fly saved us countless hours. Instead of manually compiling reports, we effortlessly produced comprehensive, up-to-date documentation with minimal effort.

Alexander Buesser

Head of Product and Engineering

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# Agentic AI powers continuous compliance

[Explore Ketryx AI Agents](https://www.ketryx.com/capabilities/ai-agents)

> Ketryx gives us a repeatable quality process, saves us time, and helps us release faster while also ensuring that we have controls for all risks.

Nicole Hollauf

Risk and Compliance Manager

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# Track every requirement, risk, and test without effort.

[Explore Self-Tracing SDLC](https://www.ketryx.com/capabilities/traceability)

> The automated traceability and risk management has streamlined our development process and made documentation much easier. Highly recommended for teams in regulated industries!

Nicole Hollauf

Risk and Compliance Manager

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# Enforce quality processes without slowing down.

[Explore AI-driven Enforcement](https://www.ketryx.com/capabilities/enforcement)

> The Ketryx platform has significantly enhanced our operational efficiency by streamlining processes that previously required manual duplication for Quality-related documentation.

Christy Hardin

Director of Quality Assurance

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# Ship FDA-compliant software in record time.

[Leverage AI Agents for speed and compliance](https://www.ketryx.com/capabilities/ai-agents)

> Ketryx updates itself as I’m working in Jira and GitHub. This tighter integration into our current tools helps us be more productive and release faster.

Aaron Berlin

SVP Development and Engineering

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Next

Ketryx is built for every team

## Meet the first AI compliance platform built to move as fast as you do. Automated, real-time, FDA-ready.

[Quality Leader\\
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Learn more\\
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**Ensure compliance is built in, not an afterthought.**\\
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"We were able to migrate our monolithic ecosystem into a single project and break it down into a desired state just within a couple of days. Ketryx delivered that because it was designed to scale."\\
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Emre Gültürk\\
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VP of Regulatory Affairs and Quality Systems, Heartflow](https://www.ketryx.com/function/quality)

[R&D Teams\\
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Learn more\\
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**Keep workflows agile while meeting the strictest FDA standards.**\\
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"Our engineers are still working with the same speed and agility, only now they are operating in a regulated environment. With Ketryx, compliance processes just run in the background."\\
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Roman Bugaev\\
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CTO, Flo Health](https://www.ketryx.com/function/developer)

[AI Product Teams\\
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Learn more\\
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**Validate AI models and automate documentation in one place.**\\
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"Ketryx helps us remain agile while delivering high-quality, AI-driven products."\\
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Alex Chan\\
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VP of Analytics and Machine Learning, Beacon Biosignals](https://www.ketryx.com/function/ai-ml)

## What our life science partners are saying

"When I compare Ketryx AI to out-of-the-box tools like Gemini or ChatGPT for regulated product development, Ketryx consistently gives me the best answers. What makes Ketryx AI different is that it’s operating inside the project itself. It’s reading the actual design history, requirements, and context of the product, rather than pulling generic answers from the web and hoping they apply."

Lucas Fernandez

Director, Medical Devices

Emre Gültürk

VP of Regulatory Affairs and Quality Systems

"With Ketryx, we automated and streamlined far more than expected. Work that would have taken us a year was completed in just 90 days because of their expertise, partnership, and platform. Had we chosen another provider, our confidence and our timeline would have looked very different. "

Tsimafei Savitski

Chief Legal and Compliance Officer

"The Ketryx platform has significantly enhanced our operational efficiency by streamlining processes for Quality-related documentation. This optimization has not only expedited the release process but also delivered measurable value to both our Quality and Engineering teams. Ketryx’s expertise and dedication to customer success have made them an indispensable partner. ”

Christy Hardin

Director of Quality Assurance

"Ketryx has greatly improved our process reliability. The seamless integration into our workflow ensures compliance without additional effort. The automated traceability and risk management has streamlined our development process and made documentation much easier. Highly recommended for teams in regulated industries!"

Nicole Hollauf

Risk and Compliance Manager

"I used a traditional ALM in the past and it didn’t have the traceability I needed. Ketryx updates itself as I’m working in Jira and GitHub. This tighter integration into our current tools helps us be more productive and release faster."

Aaron Berlin

SVP Development and Engineering

"Ketryx has allowed us to channel our hardware and software engineers’ existing set of development, testing, and documentation practices directly into the generation of compliant documentation with minimal additional burden. This has allowed us to remain agile while delivering high-quality products."

Alex Chan

VP of Analytics and Machine Learning

The Challenge

## Traditional compliance is a bottleneck

Manually tracking requirements, documenting changes, and enforcing regulations takes months instead of minutes. Ketryx AI removes the manual burden, letting your team focus on what matters—building great products.

[Preview Product](https://www.ketryx.com/on-demand-demo)

[Book a Demo](https://www.ketryx.com/schedule-demo)

Ketryx empowers compliance leaders, R&D teams, and investors to accelerate innovation without increasing risk.

90%

Faster than the old way

Build at the Speed of Tech

## Ketryx doesn’t replace your development tools. It orchestrates them.

By embedding compliance into modern product development, Ketryx makes regulatory approval, risk management, and AI validation seamless, automated, and always audit-ready.

[What is Ketryx?](https://www.ketryx.com/product)

## FDA-Ready Products, Without the Hassle

Contact us to see how Ketryx and agentic AI can accelerate your development time by up to 10X while keeping your team audit-ready.

[Preview Product](https://www.ketryx.com/on-demand-demo) [Book a Demo](https://www.ketryx.com/schedule-demo)

Develop fast. Stay compliant.

#### Product

- [What is Ketryx?](https://www.ketryx.com/product)
- [Pricing](https://www.ketryx.com/pricing)
- [Documentation](https://www.ketryx.com/capabilities/documentation)
- [Traceability](https://www.ketryx.com/capabilities/traceability)
- [AI Agents](https://www.ketryx.com/capabilities/ai-agents)
- [Integrations](https://www.ketryx.com/capabilities/integrations)
- [SBOM](https://www.ketryx.com/capabilities/sbom-software-bill-of-materials)
- [AI/ML in Medical Devices](https://www.ketryx.com/use-case/ai-ml-med-device)
- [AI for Life Sciences](https://www.ketryx.com/use-case/ai-ml-gxp-life-science)
- [Jira for 62304](https://www.ketryx.com/use-case/jira-connector)

#### Resources

- [Developer Docs](https://docs.ketryx.com/Nfv9ttHxYK0eaVZFq3wl/)
- [Blog](https://www.ketryx.com/learn/blog)
- [Support and FAQs](https://ketryx.zendesk.com/hc/en-us)
- [Webinars](https://www.ketryx.com/learn/webinars)
- [White Papers](https://www.ketryx.com/learn/white-papers)

#### About

- [Company](https://www.ketryx.com/about/company)
- [Why Ketryx](https://www.ketryx.com/about/why-ketryx)
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IntroductionKetryx

Overview of the Platform

Understanding the V

Demo Introduction

Navigating the Software Development Life Cycle

Traceability and Approval Process

Finalizing the Release

Conclusion and Call to Action
