blog/
152 pages · Updated August 30, 2026
Pages
- AI in medical imaging: the key tenets of an effective governance strategy
- GlobalData - Medical Device Network Spotlight: AI in medical imaging: the key tenets of an effective governance strategy
- The AI Reckoning in Medtech Regulatory Affairs
- Yahoo Tech: AI in medical imaging: the key tenets of an effective governance strategy
- How Ketryx is developing AI for safe medical technology in Vienna
- GS MedTech Weekly no 27: Capital Is Selective, AI Is Becoming Infrastructure, and Orthopaedics Keeps Moving
- Devices Selected for EU Tech Assessments, Breakthrough Pilot, and More Medtech Policy Picks
- AI Engineering Podcast
- You Can't Validate AI You Don't Control: Closing the Context Gap in Regulated Development
- Former Medtronic CEO Joins Ketryx Board
- Ex-Medtronic CEO Bill Hawkins joins Ketryx board
- A Complete Guide to the FDA’s AI/ML Guidance for Medical Devices
- 2023 FDA Warning Letters and Software Validation
- Agile in Theory, Waterfall in Practice: Why Regulated Teams Struggle to Ship Fast
- Ketryx’s New Integration with Azure DevOps (ADO): End-to-End Traceability for Regulated Teams
- 21 CFR Part 11 Compliance Guide for Jira (Atlassian)
- “Did We Catch Everything?” How Ketryx Turns Risk Management into Proactive Product Intelligence
- A brief overview of cloud security for standard and safety-critical software
- Best Practices for Maintaining a Requirement Traceability Matrix in Agile
- How Quality Teams Are Using AI Agents to Scale Their Impact
- AI Agents Launched to Streamline Compliance in Safety-Critical Sectors
- AI startup that streamlines medical device compliance raises $39M
- AI firm Ketryx raises $39M, adds former Medtronic CEO as investor
- As FDA moves builds out ‘Elsa,’ this AI compliance CEO underscores that need for a hybrid AI approach
- Ketryx AI Agents: How People and Agents Build Regulated Products Together
- Understanding Software as a Medical Device (SaMD)
- We Put Our Own QMS Under the Microscope. Here’s What We Found.
- From Vision to Validation: The Story Behind Ketryx's Journey to Transforming MedTech Software
- Navigating ISO 26262 and IEC 61508-3 Functional Safety Standards for Safety-Critical Software
- A Comprehensive Guide to IEC 62304: Navigating the Standard for Medical Device Software
- FDA Class II Medical Device Regulations and Compliance
- How to Validate Ketryx
- The latest (June 2023) changes to the FDA’s new premarket submission guidance
- FDA Class I Medical Device Regulations and Compliance
- Medtech compliance — not regulation — is stifling innovation
- Ketryx 2.9
- Announcing Ketryx’s UL Certification to IEC 62304, ISO 13485, and ISO 14971
- Ketryx 2.0 Release
- Recalls Are Rising. Panic Doesn’t Have To.
- Introducing Ketryx Intelligence: Accelerate Product Development Safely with Generative AI
- Inside Ketryx’s Customer Validation Package
- Why Obsessing Over Documentation Might Be Making Your Product Less Safe
- UL Certification: A Launchpad for Product Development Excellence
- Why The Epidemic In Quality Failures And What MedTechs Can Learn
- Understanding the FDA's 2026 Clinical Decision Support Software Guidance: What Medical Device Companies NTK
- FDA Traceability Matrix Requirements for Medical Devices
- Ketryx 2.8
- Modernizing the Medical Device Factory to Work With Software
- Writing Code Before Design Controls is Not Only Legal, It’s the Future of Product Development
- Why So Many Medical Device Companies Lack Real-Time Traceability and Visibility
- $14M to Build the Future of Medical Software
- Creating FDA-compliant Medical Devices at Lightning Speed with ChatGPT and Ketryx
- The Best RTM Tools for Agile Teams: Looking Beyond Excel
- Work Smarter: Ketryx’s Native Google Drive Integration
- Top of the Morning
- ISO 14971: A Comprehensive Guide to Risk Management in Medical Devices
- Should You Change Your Process Before You Update Your Tooling?
- How to Create a Design and Development File for Medical Devices
- Understanding FDA Guidance on AI in Medical Devices and Predetermined Change Control Plans (PCCPs)
- How Ketryx Works: Product Design Philosophy and Framework
- How MedTechs Can Retain Developers
- MIT Media Lab Spring Meeting 2022: E14 Startups
- FDA Predetermined Change Control Plan (PCCP): Compliance Guide
- How to generate an SBOM (Software Bill of Materials) fast
- How to Build Safer and More Reliable Software
- FDA Software Verification vs. Validation: What's the Difference?
- Ketryx raises $14m in Series A funding
- Ketryx Raises $14 Million to Boost Software Safety in Healthcare
- The FDA Just Published Free Advice for Building With AI. Here's What Your Team Needs to Know.
- Ketryx raises $39M to advance AI compliance in life sciences
- Q&A: The facts about the PATCH Act
- The Compliance Confidence Trap: What 100 Requirements Reviews Still Miss
- AI Experts Network: Innovation Labs Series
- Ketryx raises $39 million in Series B funding to expand AI compliance tools for life sciences
- Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development
- New Integrations with Jama, Polarion, ADO, and TestRail Streamline Medical Product Development
- The Ultimate Guide to Requirements Traceability Matrix (RTM)
- Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices: A Comprehensive Guide
- The Turtle Problem
- Four Bold Predictions for Medtech in 2025: AI Everywhere, Faster Releases, and Rising Risks
- Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx
- Ketryx raises $39m to advance AI compliance platform
- Ketryx 2.11
- Building the Infrastructure for Regulated AI: Announcing Ketryx's $39M Series B
- FDA Cybersecurity SBOM Regulations and Compliance Guide
- Why the FDA’s Most Common Warning Letter Might Surprise You
- 39 Millionen Dollar Investment für österreichisch-amerikanisches KI-Start-up
- How Connected Lifecycle Management Is Revolutionizing MedTech Software Development
- Three strategies for unlocking the power of continuous integration/continuous deployment (CI/CD) for AI-powered medical devices
- Ketryx 2.6
- Can MedTech Use Validated DevOps to Move as Fast as Netflix?
- Beyond the Basics: Building FDA-Compliant SBOMs for MedTech
- IEC 62304 & Requirements Traceability Matrix (RTM) in Jira: A Guide for Medical Device Companies
- Navigating the FDA's New Draft Guidance on AI-Enabled Devices
- The VentureFizz Podcast with Erez Kaminski
- Transforming Lifecycle Management
- Clinical Trial Computerized Systems Regulation Review
- From Spreadsheets to System-Level Clarity: How Medical Device Manufacturers Are Transforming Cybersecurity Threat Modeling
- MedTech Trends for 2024: Takeaways from JP Morgan's Health Conference
- How Regulated Teams Release Every Two Weeks
- SOUP Software Definition and a Guide to Software Regulations of Unknown Provenance
- Navigating Non-Product Software Validation in GxP Environments
- Ketryx 2.7
- Ketryx is now ISO 27001 certified.
- Key Takeaways from the first Safety-critical Software Meetup in Boston
- Erez Kaminski, Co-Founder & CEO at Ketryx on serving 100M+ customers and scaling regulated products
- Why Validated DevOps is the Path Forward for Regulated Software
- Ketryx Wants Its Validated AI Agents To Accelerate Compliance Workflows
- PATCH Act: How to Comply in 2023 & Beyond
- Why Change Impact Assessment Is the Hidden Bottleneck in Medical Device Development
- Regulation Isn’t Slowing MedTech. Legacy Thinking Is.
- Computer Software Assurance
- The Spotify layoff letter, a new AI model from Alibaba, and a Boston VC firm abruptly shuts down
- Three steps for traceability in medical device software development quality and compliance
- Minimizing Risk Through Model-Based Systems Engineering: A Regulatory Perspective
- Watch how Ketryx applies AI to automate compliance in regulated software
- What Makes a Company Successful at Using AI?
- How to Build Compliant Software Faster with Polarion, Jira, and Ketryx
- Who pays the bills when AI kills?
- The Future of Healthcare Is Connected & Data-Driven
- Use of AI in imaging paves the way for other medical devices
- Ketryx 2.5
- How to Stop Managing Documents and Start Managing the Work
- Spreadsheet Errors: The Hidden Risk In MedTech
- StartUPDATES: New developments from healthcare startups
- Solving the Systems Interconnectivity Problem
- AI-Assisted Change Impact Assessment: How 9 Engineers Doubled Their Completeness in Half the Time
- The Transformative Impact of Patient Apps in Healthcare
- StartUp Health Insights: GI Robotics Company Closes $42M
- FDA Cybersecurity Guidance for Medical Devices
- From Recalls to Reliability: Tools to Ensure Software Safety in MedTech
- Ketryx Raises $39M Series B from Transformation & Lightspeed to Scale AI in MedTech
- Preparing for the PATCH Act and RTA
- Ketryx Tackles Software Safety in Medical Devices Amid Growing Recalls
- Ketryx raises $18M to accelerate software development cycles in the medical industry
- Medtech AI developer Ketryx raises $14M in Series A round led by Lightspeed
- Medtech Connect Episode 6: The Latest And Greatest In Digital Health Regulations
- Ketryx Rakes In $14M to Speed Up Medical Device Development & Quality Assurance
- How to Survive FDA’s Predetermined Change Control Plan
- Mary Brook Delano Named Chief Business Officer at Ketryx
- Innovation Beat: Mass. unveils plan to improve EV charging. Is it moving fast enough?
- Ketryx expands to larger Cambridge office as demand for AI agents grows
- Ketryx raises $39M to help medical device makers ship safer products faster
- Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners
- Ketryx Raises $14M in Series A Funding
- Ketryx SaMD Blog - Ketryx
- How Can Medtechs Prepare for the FDA’s Shift Left Strategy on Cybersecurity?
- Ketryx: Application Lifecycle Management Company Raises $14 Million
- How Flo Health Built FDA-Ready Infrastructure Without Slowing Innovation
- Former Medtronic CEO joins $39M Ketryx funding round
- Digital health's top 2023 trends, wrapped
- Achieve faster product releases with Ketryx's validated AI agents