[Skip to main content](https://www.ketryx.com/learn/blog#) [Perspectives\\ \\ **We Put Our Own QMS Under the Microscope. Here’s What We Found.**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ November 5, 2025\\ \\ November 7, 2025\\ \\ Learn how our team regularly evaluates our own QMS so we can release faster while staying compliant--and see how you can do the same.\\ \\ Filter articles Checking your Browser… Verifying... Stuck? [Troubleshoot](https://challenges.cloudflare.com/cdn-cgi/challenge-platform/h/g/turnstile/f/ov2/av0/rch/ymvc0/0x4AAAAAAAQTptj2So4dx43e/auto/fbE/new/normal?lang=auto#refresh) Success! 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Panic Doesn’t Have To.**\\ \\ Paul Jones\\ \\ and \\ \\ •  \\ \\ February 11, 2026\\ \\ February 10, 2026](https://www.ketryx.com/blog/recalls-are-rising-panic-doesnt-have-to) \\ \\ Product Updates\\ **Work Smarter: Ketryx’s Native Google Drive Integration**\\ \\ Gabriel Pascualy\\ \\ and \\ \\ •  \\ \\ February 14, 2026\\ \\ February 3, 2026](https://www.ketryx.com/blog/work-smarter-ketryxs-native-google-drive-integration) \\ \\ Perspectives\\ **Inside Ketryx’s Customer Validation Package**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ December 12, 2025\\ \\ December 12, 2025](https://www.ketryx.com/blog/inside-ketryxs-customer-validation-package) \\ \\ Perspectives\\ **How Quality Teams Are Using AI Agents to Scale Their Impact**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ November 12, 2025\\ \\ November 12, 2025](https://www.ketryx.com/blog/ai-agents-quality-impact) \\ \\ Perspectives\\ **We Put Our Own QMS Under the Microscope. Here’s What We Found.**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ December 2, 2025\\ \\ November 7, 2025](https://www.ketryx.com/blog/we-put-our-own-qms-under-the-microscope-heres-what-we-found) \\ \\ Perspectives\\ **How to Stop Managing Documents and Start Managing the Work**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ November 6, 2025\\ \\ November 4, 2025](https://www.ketryx.com/blog/how-to-stop-managing-documents-and-start-managing-the-work) \\ \\ AI/ML\\ **The VentureFizz Podcast with Erez Kaminski**\\ \\ Ketryx\\ \\ and \\ \\ VentureFizz\\ \\ •  \\ \\ February 4, 2026\\ \\ September 15, 2025](https://www.ketryx.com/blog/the-venturefizz-podcast-with-erez-kaminski) \\ \\ Perspectives\\ **Building the Infrastructure for Regulated AI: Announcing Ketryx's $39M Series B**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ September 8, 2025\\ \\ September 4, 2025](https://www.ketryx.com/blog/building-the-infrastructure-for-regulated-ai-announcing-ketryx-39m-series-b) \\ \\ Perspectives\\ **Agile in Theory, Waterfall in Practice: Why Regulated Teams Struggle to Ship Fast**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ August 28, 2025\\ \\ August 27, 2025](https://www.ketryx.com/blog/agile-in-theory-waterfall-in-practice-why-regulated-teams-struggle-to-ship-fast) \\ \\ Perspectives\\ **Why Obsessing Over Documentation Might Be Making Your Product Less Safe**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ August 26, 2025\\ \\ August 22, 2025](https://www.ketryx.com/blog/document-centric-approach) \\ \\ Perspectives\\ **How Regulated Teams Release Every Two Weeks**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ August 20, 2025\\ \\ August 19, 2025](https://www.ketryx.com/blog/how-regulated-teams-release-every-two-weeks) \\ \\ Perspectives\\ **How to Validate Ketryx**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ August 13, 2025\\ \\ August 12, 2025](https://www.ketryx.com/blog/how-to-validate-ketryx) \\ \\ In the News\\ **Use of AI in imaging paves the way for other medical devices**\\ \\ Ketryx\\ \\ and \\ \\ Boston Business Journal\\ \\ •  \\ \\ August 5, 2025\\ \\ July 31, 2025](https://www.ketryx.com/blog/use-of-ai-in-imaging-paves-the-way-for-other-medical-devices) \\ \\ In the News\\ **Ketryx expands to larger Cambridge office as demand for AI agents grows**\\ \\ Ketryx\\ \\ and \\ \\ BostInno\\ \\ •  \\ \\ July 10, 2025\\ \\ July 9, 2025](https://www.ketryx.com/blog/ketryx-expands-to-larger-cambridge-office-as-demand-for-ai-agents-grows) \\ \\ In the News\\ **As FDA moves builds out ‘Elsa,’ this AI compliance CEO underscores that need for a hybrid AI approach**\\ \\ Ketryx\\ \\ and \\ \\ R&D World\\ \\ •  \\ \\ June 17, 2025\\ \\ June 16, 2025](https://www.ketryx.com/blog/as-fda-moves-builds-out-elsa-this-ai-compliance-ceo-underscores-that-need-for-a-hybrid-ai-approach) \\ \\ Academy\\ **How to Build Compliant Software Faster with Polarion, Jira, and Ketryx**\\ \\ Ketryx\\ \\ and \\ \\ •  \\ \\ June 11, 2025\\ \\ June 11, 2025](https://www.ketryx.com/blog/doing-agile-development-with-jira-and-polarion) \\ \\ In the News\\ **Ketryx Wants Its Validated AI Agents To Accelerate Compliance Workflows**\\ \\ Shubham Singh\\ \\ and \\ \\ Citeline\\ \\ •  \\ \\ May 27, 2025\\ \\ May 15, 2025](https://www.ketryx.com/blog/ketryx-wants-its-validated-ai-agents-to-accelerate-compliance-workflows) \\ \\ In the News\\ **Achieve faster product releases with Ketryx's validated AI agents**\\ \\ Elizabeth Engler Modic\\ \\ and \\ \\ Today's Medical Developments\\ \\ •  \\ \\ May 2, 2025\\ \\ May 2, 2025](https://www.ketryx.com/blog/achieve-faster-product-releases-with-ketryxs-validated-ai-agents) \\ \\ In the News\\ **AI Agents Launched to Streamline Compliance in Safety-Critical Sectors**\\ \\ Scarlett Evans\\ \\ and \\ \\ AI Business\\ \\ •  \\ \\ May 2, 2025\\ \\ May 2, 2025](https://www.ketryx.com/blog/ai-agents-launched-to-streamline-compliance-in-safety-critical-sectors) \\ \\ Product Updates\\ **Ketryx AI Agents: How People and Agents Build Regulated Products Together**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ May 1, 2025\\ \\ May 1, 2025](https://www.ketryx.com/blog/ketryx-ai-agents) .svg).svg)\\ \\ Product Updates\\ **Ketryx’s New Integration with Azure DevOps (ADO): End-to-End Traceability for Regulated Teams**\\ \\ Milan Dzenovljanovic\\ \\ and \\ \\ •  \\ \\ April 13, 2025\\ \\ March 20, 2025](https://www.ketryx.com/blog/ado-integration) \\ \\ Academy\\ **A Complete Guide to the FDA’s AI/ML Guidance for Medical Devices**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ February 20, 2025](https://www.ketryx.com/blog/a-complete-guide-to-the-fdas-ai-ml-guidance-for-medical-devices) \\ \\ Academy\\ **Understanding Software as a Medical Device (SaMD)**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ March 25, 2025\\ \\ January 31, 2025](https://www.ketryx.com/blog/understanding-software-as-a-medical-device-samd) \\ \\ In the News\\ **Why Validated DevOps is the Path Forward for Regulated Software**\\ \\ Erez Kaminski\\ \\ and \\ \\ Erez Kaminski\\ \\ devops.com\\ \\ •  \\ \\ February 4, 2026\\ \\ January 30, 2025](https://www.ketryx.com/blog/why-validated-devops-is-the-path-forward-for-regulated-software) \\ \\ News video\\ **Spreadsheet Errors: The Hidden Risk In MedTech**\\ \\ Erez Kaminski\\ \\ and \\ \\ Forbes\\ \\ •  \\ \\ February 4, 2026\\ \\ January 28, 2025](https://www.ketryx.com/blog/spreadsheet-errors-the-hidden-risk-in-medtech) \\ \\ Academy\\ **FDA Software Verification vs. Validation: What's the Difference?**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ January 27, 2025](https://www.ketryx.com/blog/fda-software-verification-vs-validation-whats-the-difference) .svg)\\ \\ Product Updates\\ **Ketryx 2.11**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ May 12, 2025\\ \\ January 27, 2025](https://www.ketryx.com/blog/ketryx-2-11) \\ \\ Academy\\ **How to Create a Design History File (DHF) for Medical Devices**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ January 15, 2025](https://www.ketryx.com/blog/how-to-create-a-design-history-file-dhf-for-medical-devices) \\ \\ Perspectives\\ **Navigating the FDA's New Draft Guidance on AI-Enabled Devices**\\ \\ Jenn Dixon\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ January 14, 2025](https://www.ketryx.com/blog/navigating-the-fdas-new-draft-guidance-on-ai-enabled-devices) \\ \\ In the News\\ **Transforming Lifecycle Management**\\ \\ Sandra Rodriguez\\ \\ and \\ \\ Axendia\\ \\ •  \\ \\ February 11, 2025\\ \\ January 10, 2025](https://www.ketryx.com/blog/transforming-lifecycle-management) \\ \\ In the News\\ **Four Bold Predictions for Medtech in 2025: AI Everywhere, Faster Releases, and Rising Risks**\\ \\ Erez Kaminski\\ \\ and \\ \\ MPO News\\ \\ •  \\ \\ February 11, 2025\\ \\ December 18, 2024](https://www.ketryx.com/blog/four-bold-predictions-for-medtech-in-2025-ai-everywhere-faster-releases-and-rising-risks) \\ \\ In the News\\ **Three strategies for unlocking the power of continuous integration/continuous deployment (CI/CD) for AI-powered medical devices**\\ \\ Erez Kaminski\\ \\ and \\ \\ Medical Design & Outsourcing\\ \\ •  \\ \\ February 11, 2025\\ \\ November 12, 2024](https://www.ketryx.com/blog/three-strategies-for-unlocking-the-power-of-continuous-integration-continuous-deployment-ci-cd-for-ai-powered-medical-devices) \\ \\ Perspectives\\ **Why So Many Medical Device Companies Lack Real-Time Traceability and Visibility**\\ \\ Jake Stowe\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ November 12, 2024](https://www.ketryx.com/blog/why-so-many-medical-device-companies-lack-real-time-traceability-and-visibility) \\ \\ Perspectives\\ **How MedTechs Can Retain Developers**\\ \\ Jan Pöschko\\ \\ and \\ \\ •  \\ \\ March 25, 2025\\ \\ November 11, 2024](https://www.ketryx.com/blog/how-medtechs-can-retain-developers) \\ \\ In the News\\ **Why The Epidemic In Quality Failures And What MedTechs Can Learn**\\ \\ Erez Kaminski\\ \\ and \\ \\ Forbes\\ \\ •  \\ \\ February 11, 2025\\ \\ November 8, 2024](https://www.ketryx.com/blog/why-the-epidemic-in-quality-failures-and-what-medtechs-can-learn) \\ \\ Perspectives\\ **How Ketryx Works: Product Design Philosophy and Framework**\\ \\ Jan Pöschko\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ November 8, 2024](https://www.ketryx.com/blog/how-ketryx-works-product-design-philosophy-and-framework) \\ \\ Academy\\ **ISO 14971: A Comprehensive Guide to Risk Management in Medical Devices**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ April 24, 2025\\ \\ November 7, 2024](https://www.ketryx.com/blog/iso-14971-a-comprehensive-guide-to-risk-management-in-medical-devices) .svg)\\ \\ Academy\\ **A Comprehensive Guide to IEC 62304: Navigating the Standard for Medical Device Software**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ October 23, 2024](https://www.ketryx.com/blog/a-comprehensive-guide-to-iec-62304-navigating-the-standard-for-medical-device-software) \\ \\ Academy\\ **Understanding FDA Guidance on AI in Medical Devices and Predetermined Change Control Plans (PCCPs)**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ October 22, 2024](https://www.ketryx.com/blog/understanding-fda-guidance-on-ai-in-medical-devices-and-predetermined-change-control-plans-pccps) .svg)\\ \\ Perspectives\\ **Should You Change Your Process Before You Update Your Tooling?**\\ \\ Jake Stowe\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ October 16, 2024](https://www.ketryx.com/blog/process-and-tooling) \\ \\ Academy\\ **FDA Cybersecurity Guidance for Medical Devices**\\ \\ Gabriel Pascualy\\ \\ and \\ \\ •  \\ \\ March 25, 2025\\ \\ October 15, 2024](https://www.ketryx.com/blog/fda-cybersecurity-guidance-for-medical-devices) .png)\\ \\ Product Updates\\ **Ketryx 2.9**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ October 14, 2024](https://www.ketryx.com/blog/ketryx-2-9) \\ \\ Academy\\ **Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices: A Comprehensive Guide**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ October 11, 2024](https://www.ketryx.com/blog/implementing-pccp-ci-cd-for-ai-ml-enabled-medical-devices-a-comprehensive-guide) \\ \\ Academy\\ **FDA Class II Medical Device Regulations and Compliance**\\ \\ Jenn Dixon\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ October 3, 2024](https://www.ketryx.com/blog/fda-class-ii-medical-device-regulations-and-compliance) \\ \\ Academy\\ **FDA Class I Medical Device Regulations and Compliance**\\ \\ Jenn Dixon\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ October 2, 2024](https://www.ketryx.com/blog/fda-class-i-medical-device-regulations-and-compliance) \\ \\ Perspectives\\ **From Vision to Validation: The Story Behind Ketryx's Journey to Transforming MedTech Software**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ October 1, 2024](https://www.ketryx.com/blog/story-of-ketryx) \\ \\ Academy\\ **Medical Device Software Validation and Verification for Regulatory Compliance**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ September 30, 2024](https://www.ketryx.com/blog/medical-device-software-validation-and-verification-for-regulatory-compliance) \\ \\ In the News\\ **How to Survive FDA’s Predetermined Change Control Plan**\\ \\ Erez Kaminski\\ \\ and \\ \\ MD+DI\\ \\ •  \\ \\ February 11, 2025\\ \\ September 10, 2024](https://www.ketryx.com/blog/how-to-survive-fdas-predetermined-change-control-plan) \\ \\ Perspectives\\ **Modernizing the Medical Device Factory to Work With Software**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ September 4, 2024](https://www.ketryx.com/blog/modernizing-the-medical-device-factory-to-work-with-software) \\ \\ In the News\\ **Ketryx Tackles Software Safety in Medical Devices Amid Growing Recalls**\\ \\ Jenna Philpott\\ \\ and \\ \\ Medical Device Network\\ \\ •  \\ \\ February 11, 2025\\ \\ September 2, 2024](https://www.ketryx.com/blog/ketryx-tackles-software-safety-in-medical-devices-amid-growing-recalls) .svg)\\ \\ Perspectives\\ **Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development**\\ \\ Jan Pöschko\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ August 29, 2024](https://www.ketryx.com/blog/constructive-constraints-enforcement-faster-medical-software-development) .png)\\ \\ Product Updates\\ **Ketryx 2.8**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ August 21, 2024](https://www.ketryx.com/blog/ketryx-2-8) \\ \\ Perspectives\\ **Beyond the Basics: Building FDA-Compliant SBOMs for MedTech**\\ \\ Gabriel Pascualy\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ August 8, 2024](https://www.ketryx.com/blog/building-fda-compliant-sboms-for-medtech) \\ \\ Perspectives\\ **How Connected Lifecycle Management Is Revolutionizing MedTech Software Development**\\ \\ Zack Jha\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ August 5, 2024](https://www.ketryx.com/blog/how-connected-lifecycle-management-is-revolutionizing-medtech-software-development) \\ \\ Perspectives\\ **Can MedTech Use Validated DevOps to Move as Fast as Netflix?**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ July 31, 2024](https://www.ketryx.com/blog/medtech-validated-devops-fast) \\ \\ In the News\\ **Medtech compliance — not regulation — is stifling innovation**\\ \\ Erez Kaminski\\ \\ and \\ \\ STATNews\\ \\ •  \\ \\ February 4, 2026\\ \\ July 26, 2024](https://www.ketryx.com/blog/medtech-compliance-not-regulation-is-stifling-innovation) \\ \\ In the News\\ **From Recalls to Reliability: Tools to Ensure Software Safety in MedTech**\\ \\ Erez Kaminski\\ \\ and \\ \\ MedCity News\\ \\ •  \\ \\ February 11, 2025\\ \\ June 14, 2024](https://www.ketryx.com/blog/from-recalls-to-reliability-tools-to-ensure-software-safety-in-medtech) \\ \\ Product Updates\\ **Ketryx 2.7**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ June 3, 2024](https://www.ketryx.com/blog/ketryx-2-7) \\ \\ Perspectives\\ **FDA Predetermined Change Control Plan (PCCP): Compliance Guide**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ May 9, 2024](https://www.ketryx.com/blog/pccp-compliance) \\ \\ In the News\\ **UL Certification: A Launchpad for Product Development Excellence**\\ \\ Erez Kaminski\\ \\ and \\ \\ MedTech Intelligence\\ \\ •  \\ \\ February 11, 2025\\ \\ May 1, 2024](https://www.ketryx.com/blog/ul-certification-a-launchpad-for-product-development-excellence) \\ \\ Perspectives\\ **21 CFR Part 11 Compliance Guide for Jira (Atlassian)**\\ \\ Jake Stowe\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ April 12, 2024](https://www.ketryx.com/blog/21-cfr-part-11-compliance-guide-for-jira-atlassian) \\ \\ Product Updates\\ **Ketryx 2.6**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ March 25, 2025\\ \\ March 29, 2024](https://www.ketryx.com/blog/ketryx-2-6) \\ \\ In the News\\ **Announcing Ketryx’s UL Certification to IEC 62304, ISO 13485, and ISO 14971**\\ \\ Paul Jones\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ March 6, 2024](https://www.ketryx.com/blog/announcing-ketryxs-ul-certification) \\ \\ Product Updates\\ **Ketryx 2.5**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ February 13, 2024](https://www.ketryx.com/blog/ketryx-2-5) \\ \\ Perspectives\\ **MedTech Trends for 2024: Takeaways from JP Morgan's Health Conference**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ January 25, 2024](https://www.ketryx.com/blog/medtech-trends-for-2024-takeaways-from-jp-morgans-health-conference) \\ \\ Perspectives\\ **$14M to Build the Future of Medical Software**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ February 11, 2025\\ \\ December 5, 2023](https://www.ketryx.com/blog/14m-to-build-the-future-of-medical-software) \\ \\ Perspectives\\ **IEC 62304 & Requirements Traceability Matrix (RTM) in Jira: A Guide for Medical Device Companies**\\ \\ Jan Pöschko\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ November 13, 2023](https://www.ketryx.com/blog/iec-62304-requirements-traceability-matrix-rtm-in-jira-a-guide-for-medical-device-companies) \\ \\ Perspectives\\ **How to generate an SBOM (Software Bill of Materials) fast**\\ \\ Jan Pöschko\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ November 2, 2023](https://www.ketryx.com/blog/how-to-generate-an-sbom-software-bill-of-materials-fast) \\ \\ Perspectives\\ **The latest (June 2023) changes to the FDA’s new premarket submission guidance**\\ \\ Lee Chickering\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ October 16, 2023](https://www.ketryx.com/blog/the-latest-june-2023-changes-to-the-fdas-new-premarket-submission-guidance) \\ \\ Perspectives\\ **The Turtle Problem**\\ \\ Jake Stowe\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ September 12, 2023](https://www.ketryx.com/blog/the-turtle-problem) \\ \\ Perspectives\\ **Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx**\\ \\ Paul Jones\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ September 12, 2023](https://www.ketryx.com/blog/simplifying-510k-submissions-with-fdas-estar-program-and-ketryx) \\ \\ Perspectives\\ **Best Practices for Maintaining a Requirement Traceability Matrix in Agile**\\ \\ Jake Stowe\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ September 12, 2023](https://www.ketryx.com/blog/best-practices-for-maintaining-a-requirement-traceability-matrix-in-agile) \\ \\ In the News\\ **Three steps for traceability in medical device software development quality and compliance**\\ \\ Paul Jones\\ \\ and \\ \\ Medical Design and Outsourcing \\ \\ •  \\ \\ February 11, 2025\\ \\ September 7, 2023](https://www.ketryx.com/blog/three-steps-for-traceability-in-medical-device-software-development-quality-and-compliance) \\ \\ In the News\\ **Q&A: The facts about the PATCH Act**\\ \\ Kiays Khalil\\ \\ and \\ \\ Medical Device Network \\ \\ •  \\ \\ February 11, 2025\\ \\ September 4, 2023](https://www.ketryx.com/blog/q-a-the-facts-about-the-patch-act) \\ \\ Perspectives\\ **Why the FDA’s Most Common Warning Letter Might Surprise You**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ August 24, 2023](https://www.ketryx.com/blog/why-the-fdas-most-common-warning-letter-might-surprise-you) \\ \\ Perspectives\\ **PATCH Act: How to Comply in 2023 & Beyond**\\ \\ John Koontz\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ August 16, 2023](https://www.ketryx.com/blog/patch-act-how-to-comply-in-2023-beyond) \\ \\ Perspectives\\ **The Best RTM Tools for Agile Teams: Looking Beyond Excel**\\ \\ Jake Stowe\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ August 9, 2023](https://www.ketryx.com/blog/the-best-rtm-tools-for-agile-teams-looking-beyond-excel) \\ \\ Perspectives\\ **Clinical Trial Computerized Systems Regulation Review**\\ \\ Jake Stowe\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ August 9, 2023](https://www.ketryx.com/blog/clinical-trial-computerized-systems-regulation-review) \\ \\ Perspectives\\ **2023 FDA Warning Letters and Software Validation**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ August 9, 2023](https://www.ketryx.com/blog/2023-fda-warning-letters-and-software-validation) \\ \\ In the News\\ **AI Experts Network: Innovation Labs Series**\\ \\ and \\ \\ AI Expert Network\\ \\ •  \\ \\ February 11, 2025\\ \\ August 4, 2023](https://www.ketryx.com/blog/ai-experts-network-innovation-labs-series) \\ \\ In the News\\ **Who pays the bills when AI kills?**\\ \\ Erez Kaminski\\ \\ and \\ \\ The Hill\\ \\ •  \\ \\ February 11, 2025\\ \\ July 20, 2023](https://www.ketryx.com/blog/who-pays-the-bills-when-ai-kills) \\ \\ Academy\\ **FDA Cybersecurity SBOM Regulations and Compliance Guide**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ July 19, 2023](https://www.ketryx.com/blog/fda-drops-an-sbom) \\ \\ Perspectives\\ **The Ultimate Guide to Requirements Traceability Matrix (RTM)**\\ \\ Jake Stowe\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ June 19, 2023](https://www.ketryx.com/blog/the-ultimate-guide-to-requirements-traceability-matrix-rtm) \\ \\ In the News\\ **How to Build Safer and More Reliable Software**\\ \\ Erez Kaminski\\ \\ and \\ \\ builtin.com\\ \\ •  \\ \\ February 11, 2025\\ \\ June 14, 2023](https://www.ketryx.com/blog/how-to-build-safer-and-more-reliable-software) \\ \\ In the News\\ **Medtech Connect Episode 6: The Latest And Greatest In Digital Health Regulations**\\ \\ and \\ \\ Citeline\\ \\ •  \\ \\ February 11, 2025\\ \\ June 9, 2023](https://www.ketryx.com/blog/medtech-connect-episode-6-the-latest-and-greatest-in-digital-health-regulations) \\ \\ In the News\\ **Solving the Systems Interconnectivity Problem**\\ \\ Jake Stowe\\ \\ and \\ \\ MD+DI\\ \\ •  \\ \\ February 11, 2025\\ \\ June 1, 2023](https://www.ketryx.com/blog/solving-the-systems-interconnectivity-problem-2) \\ \\ Perspectives\\ **FDA Traceability Matrix Requirements for Medical Devices**\\ \\ Jake Stowe\\ \\ and \\ \\ •  \\ \\ February 11, 2025\\ \\ May 26, 2023](https://www.ketryx.com/blog/traceability-101) \\ \\ Perspectives\\ **SOUP Software Definition and a Guide to Software Regulations of Unknown Provenance**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ February 11, 2025\\ \\ May 12, 2023](https://www.ketryx.com/blog/what-is-soup) \\ \\ Product Updates\\ **Ketryx 2.0 Release**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ March 19, 2025\\ \\ May 11, 2023](https://www.ketryx.com/blog/ketryx-2-0-release) \\ \\ In the News\\ **How Can Medtechs Prepare for the FDA’s Shift Left Strategy on Cybersecurity?**\\ \\ Erez Kaminski\\ \\ and \\ \\ MedCity News\\ \\ •  \\ \\ February 11, 2025\\ \\ May 10, 2023](https://www.ketryx.com/blog/how-can-medtechs-prepare-for-the-fdas-shift-left-strategy-on-cybersecurity) \\ \\ Perspectives\\ **Computer Software Assurance**\\ \\ John Koontz\\ \\ and \\ \\ •  \\ \\ February 11, 2025\\ \\ April 17, 2023](https://www.ketryx.com/blog/computer-software-assurance) \\ \\ Perspectives\\ **A brief overview of cloud security for standard and safety-critical software**\\ \\ John Koontz\\ \\ and \\ \\ •  \\ \\ February 11, 2025\\ \\ April 17, 2023](https://www.ketryx.com/blog/a-brief-overview-of-cloud-security) \\ \\ Perspectives\\ **Key Takeaways from the first Safety-critical Software Meetup in Boston**\\ \\ Erez Kaminski\\ \\ and \\ \\ •  \\ \\ February 11, 2025\\ \\ April 13, 2023](https://www.ketryx.com/blog/key-takeaways-from-the-first-safety-critical-software-meetup-in-boston) \\ \\ Perspectives\\ **Creating FDA-compliant Medical Devices at Lightning Speed with ChatGPT and Ketryx**\\ \\ Felipe Asfura\\ \\ and \\ \\ •  \\ \\ March 14, 2025\\ \\ April 13, 2023](https://www.ketryx.com/blog/chatgpt-and-ketryx) \\ \\ In the News\\ **The Future of Healthcare Is Connected & Data-Driven**\\ \\ Omar Ford\\ \\ and \\ \\ mddonline.com\\ \\ •  \\ \\ February 11, 2025\\ \\ November 30, 2022](https://www.ketryx.com/blog/the-future-of-healthcare-is-connected-data-driven) \\ \\ In the News\\ **MIT Media Lab Spring Meeting 2022: E14 Startups**\\ \\ Sarah Beckmann\\ \\ and \\ \\ media.mit.edu\\ \\ •  \\ \\ February 11, 2025\\ \\ April 6, 2022](https://www.ketryx.com/blog/mit-media-lab-spring-meeting-2022-e14-startups) \\ \\ In the News\\ **What Makes a Company Successful at Using AI?**\\ \\ Vijay D’Silva and Bruce Lawler\\ \\ and \\ \\ hbr.org\\ \\ •  \\ \\ February 11, 2025\\ \\ February 28, 2022](https://www.ketryx.com/blog/what-makes-a-company-successful-at-using-ai) \\ \\ In the News\\ **The Transformative Impact of Patient Apps in Healthcare**\\ \\ and \\ \\ healthtechbuild.com\\ \\ •  \\ \\ March 19, 2025\\ \\ August 9, 2021](https://www.ketryx.com/blog/the-transformative-impact-of-patient-apps-in-healthcare) Sorry, no results for this filter combination. 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