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AI/ML
The Compliance Confidence Trap: What 100 Requirements Reviews Still Miss
Megan Mannino
and
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March 20, 2026
March 20, 2026
Academy
Navigating ISO 26262 and IEC 61508-3 Functional Safety Standards for Safety-Critical Software
Yashaswini Maregowda
and
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March 20, 2026
March 18, 2026
AI/ML
“Did We Catch Everything?” How Ketryx Turns Risk Management into Proactive Product Intelligence
Megan Mannino
and
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March 19, 2026
March 12, 2026
Perspectives
Minimizing Risk Through Model-Based Systems Engineering: A Regulatory Perspective
Paul Jones
and
•
March 19, 2026
March 9, 2026
AI/ML
AI-Assisted Change Impact Assessment: How 9 Engineers Doubled Their Completeness in Half the Time
Megan Mannino
and
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March 19, 2026
March 3, 2026
Traceability
Why Change Impact Assessment Is the Hidden Bottleneck in Medical Device Development
Megan Mannino
and
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March 19, 2026
February 19, 2026
Perspectives
Recalls Are Rising. Panic Doesn’t Have To.
Paul Jones
and
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March 19, 2026
February 10, 2026
Product Updates
Work Smarter: Ketryx’s Native Google Drive Integration
Gabriel Pascualy
and
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March 19, 2026
February 3, 2026
Perspectives
Inside Ketryx’s Customer Validation Package
Lee Chickering
and
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March 19, 2026
December 12, 2025
Perspectives
How Quality Teams Are Using AI Agents to Scale Their Impact
Lee Chickering
and
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March 19, 2026
November 12, 2025
Perspectives
We Put Our Own QMS Under the Microscope. Here’s What We Found.
Lee Chickering
and
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March 19, 2026
November 7, 2025
Perspectives
How to Stop Managing Documents and Start Managing the Work
Lee Chickering
and
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March 19, 2026
November 4, 2025
AI/ML
The VentureFizz Podcast with Erez Kaminski
Ketryx
and
VentureFizz
•
March 19, 2026
September 15, 2025
Perspectives
Building the Infrastructure for Regulated AI: Announcing Ketryx's $39M Series B
Erez Kaminski
and
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March 19, 2026
September 4, 2025
Perspectives
Agile in Theory, Waterfall in Practice: Why Regulated Teams Struggle to Ship Fast
Lee Chickering
and
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March 19, 2026
August 27, 2025
Perspectives
Why Obsessing Over Documentation Might Be Making Your Product Less Safe
Lee Chickering
and
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March 19, 2026
August 22, 2025
Perspectives
How Regulated Teams Release Every Two Weeks
Lee Chickering
and
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March 19, 2026
August 19, 2025
In the News
Use of AI in imaging paves the way for other medical devices
Ketryx
and
Boston Business Journal
•
March 19, 2026
July 31, 2025
In the News
Ketryx expands to larger Cambridge office as demand for AI agents grows
Ketryx
and
BostInno
•
March 19, 2026
July 9, 2025
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
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March 19, 2026
June 16, 2025
Academy
How to Build Compliant Software Faster with Polarion, Jira, and Ketryx
Ketryx
and
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March 19, 2026
June 11, 2025
In the News
Ketryx Wants Its Validated AI Agents To Accelerate Compliance Workflows
Shubham Singh
and
Citeline
•
May 27, 2025
May 15, 2025
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
In the News
AI Agents Launched to Streamline Compliance in Safety-Critical Sectors
Scarlett Evans
and
AI Business
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May 2, 2025
May 2, 2025
Product Updates
Ketryx AI Agents: How People and Agents Build Regulated Products Together
Erez Kaminski
and
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March 19, 2026
May 1, 2025
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Product Updates
Ketryx’s New Integration with Azure DevOps (ADO): End-to-End Traceability for Regulated Teams
Milan Dzenovljanovic
and
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March 19, 2026
March 20, 2025
Academy
A Complete Guide to the FDA’s AI/ML Guidance for Medical Devices
Lee Chickering
and
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March 19, 2026
February 20, 2025
Academy
Understanding Software as a Medical Device (SaMD)
Lee Chickering
and
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March 19, 2026
January 31, 2025
In the News
Why Validated DevOps is the Path Forward for Regulated Software
Erez Kaminski
and
Erez Kaminski
devops.com
•
March 19, 2026
January 30, 2025
News video
Spreadsheet Errors: The Hidden Risk In MedTech
Erez Kaminski
and
Forbes
•
March 19, 2026
January 28, 2025
Academy
FDA Software Verification vs. Validation: What's the Difference?
Lee Chickering
and
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March 19, 2026
January 27, 2025
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Product Announcements
New Integrations with Jama, Polarion, ADO, and TestRail Streamline Medical Product Development
Milan Dzenovljanovic
and
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March 19, 2026
January 17, 2025
Academy
How to Create a Design History File (DHF) for Medical Devices
Lee Chickering
and
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March 19, 2025
January 15, 2025
Perspectives
Navigating the FDA's New Draft Guidance on AI-Enabled Devices
Jenn Dixon
and
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March 19, 2025
January 14, 2025
In the News
Transforming Lifecycle Management
Sandra Rodriguez
and
Axendia
•
March 19, 2026
January 10, 2025
Product Announcements
Introducing Ketryx Intelligence: Accelerate Product Development Safely with Generative AI
Erez Kaminski
and
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March 19, 2026
December 30, 2024
In the News
Four Bold Predictions for Medtech in 2025: AI Everywhere, Faster Releases, and Rising Risks
Erez Kaminski
and
MPO News
•
March 19, 2026
December 18, 2024
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
•
March 19, 2026
November 12, 2024
Perspectives
Why So Many Medical Device Companies Lack Real-Time Traceability and Visibility
Jake Stowe
and
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March 19, 2026
November 12, 2024
In the News
Why The Epidemic In Quality Failures And What MedTechs Can Learn
Erez Kaminski
and
Forbes
•
March 19, 2026
November 8, 2024
Perspectives
How Ketryx Works: Product Design Philosophy and Framework
Jan Pöschko
and
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March 19, 2026
November 8, 2024
Academy
ISO 14971: A Comprehensive Guide to Risk Management in Medical Devices
Lee Chickering
and
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March 19, 2026
November 7, 2024
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Academy
A Comprehensive Guide to IEC 62304: Navigating the Standard for Medical Device Software
Lee Chickering
and
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March 19, 2026
October 23, 2024
Academy
Understanding FDA Guidance on AI in Medical Devices and Predetermined Change Control Plans (PCCPs)
Lee Chickering
and
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March 19, 2026
October 22, 2024
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Perspectives
Should You Change Your Process Before You Update Your Tooling?
Jake Stowe
and
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March 19, 2026
October 16, 2024
Academy
FDA Cybersecurity Guidance for Medical Devices
Gabriel Pascualy
and
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March 19, 2026
October 15, 2024
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Academy
Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices: A Comprehensive Guide
Lee Chickering
and
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March 19, 2026
October 11, 2024
Academy
FDA Class II Medical Device Regulations and Compliance
Jenn Dixon
and
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March 19, 2026
October 3, 2024
Academy
FDA Class I Medical Device Regulations and Compliance
Jenn Dixon
and
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March 19, 2026
October 2, 2024
Perspectives
From Vision to Validation: The Story Behind Ketryx's Journey to Transforming MedTech Software
Erez Kaminski
and
•
March 19, 2026
October 1, 2024
In the News
How to Survive FDA’s Predetermined Change Control Plan
Erez Kaminski
and
MD+DI
•
March 19, 2026
September 10, 2024
Perspectives
Modernizing the Medical Device Factory to Work With Software
Erez Kaminski
and
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March 19, 2026
September 4, 2024
In the News
Ketryx Tackles Software Safety in Medical Devices Amid Growing Recalls
Jenna Philpott
and
Medical Device Network
•
March 19, 2026
September 2, 2024
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Perspectives
Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development
Jan Pöschko
and
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March 19, 2026
August 29, 2024
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Perspectives
Beyond the Basics: Building FDA-Compliant SBOMs for MedTech
Gabriel Pascualy
and
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March 19, 2026
August 8, 2024
Perspectives
How Connected Lifecycle Management Is Revolutionizing MedTech Software Development
Zack Jha
and
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March 19, 2026
August 5, 2024
Perspectives
Can MedTech Use Validated DevOps to Move as Fast as Netflix?
Erez Kaminski
and
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March 19, 2026
July 31, 2024
In the News
Medtech compliance — not regulation — is stifling innovation
Erez Kaminski
and
STATNews
•
March 19, 2026
July 26, 2024
In the News
From Recalls to Reliability: Tools to Ensure Software Safety in MedTech
Erez Kaminski
and
MedCity News
•
March 19, 2026
June 14, 2024
Perspectives
FDA Predetermined Change Control Plan (PCCP): Compliance Guide
Lee Chickering
and
•
March 19, 2026
May 9, 2024
In the News
UL Certification: A Launchpad for Product Development Excellence
Erez Kaminski
and
MedTech Intelligence
•
March 19, 2026
May 1, 2024
Perspectives
21 CFR Part 11 Compliance Guide for Jira (Atlassian)
Jake Stowe
and
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March 19, 2026
April 12, 2024
In the News
Announcing Ketryx’s UL Certification to IEC 62304, ISO 13485, and ISO 14971
Paul Jones
and
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March 19, 2026
March 6, 2024
Perspectives
MedTech Trends for 2024: Takeaways from JP Morgan's Health Conference
Erez Kaminski
and
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March 19, 2026
January 25, 2024
Perspectives
$14M to Build the Future of Medical Software
Erez Kaminski
and
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March 19, 2026
December 5, 2023
Perspectives
IEC 62304 & Requirements Traceability Matrix (RTM) in Jira: A Guide for Medical Device Companies
Jan Pöschko
and
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March 19, 2025
November 13, 2023
Perspectives
How to generate an SBOM (Software Bill of Materials) fast
Jan Pöschko
and
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March 19, 2026
November 2, 2023
Perspectives
The latest (June 2023) changes to the FDA’s new premarket submission guidance
Lee Chickering
and
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March 19, 2025
October 16, 2023
Academy
Preparing for the PATCH Act and RTA
MedTech Intelligence Staff
and
MedTech Intelligence
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March 19, 2026
September 27, 2023
Perspectives
Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx
Paul Jones
and
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March 19, 2025
September 12, 2023
Perspectives
Best Practices for Maintaining a Requirement Traceability Matrix in Agile
Jake Stowe
and
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March 19, 2026
September 12, 2023
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
In the News
Q&A: The facts about the PATCH Act
Kiays Khalil
and
Medical Device Network
•
March 19, 2026
September 4, 2023
Perspectives
Why the FDA’s Most Common Warning Letter Might Surprise You
Erez Kaminski
and
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March 19, 2026
August 24, 2023
Perspectives
PATCH Act: How to Comply in 2023 & Beyond
John Koontz
and
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March 19, 2026
August 16, 2023
Perspectives
The Best RTM Tools for Agile Teams: Looking Beyond Excel
Jake Stowe
and
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March 19, 2026
August 9, 2023
Perspectives
Clinical Trial Computerized Systems Regulation Review
Jake Stowe
and
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March 19, 2026
August 9, 2023
Perspectives
2023 FDA Warning Letters and Software Validation
Erez Kaminski
and
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March 19, 2026
August 9, 2023
In the News
AI Experts Network: Innovation Labs Series
and
AI Expert Network
•
February 11, 2025
August 4, 2023
In the News
Who pays the bills when AI kills?
Erez Kaminski
and
The Hill
•
February 11, 2025
July 20, 2023
Academy
FDA Cybersecurity SBOM Regulations and Compliance Guide
Erez Kaminski
and
•
March 19, 2026
July 19, 2023
Perspectives
The Ultimate Guide to Requirements Traceability Matrix (RTM)
Jake Stowe
and
•
March 19, 2026
June 19, 2023
In the News
How to Build Safer and More Reliable Software
Erez Kaminski
and
builtin.com
•
March 19, 2026
June 14, 2023
In the News
Medtech Connect Episode 6: The Latest And Greatest In Digital Health Regulations
Citeline
and
Citeline
•
March 19, 2026
June 9, 2023
In the News
Solving the Systems Interconnectivity Problem
Jake Stowe
and
MD+DI
•
March 19, 2026
June 1, 2023
Perspectives
FDA Traceability Matrix Requirements for Medical Devices
Jake Stowe
and
•
March 19, 2026
May 26, 2023
Perspectives
SOUP Software Definition and a Guide to Software Regulations of Unknown Provenance
Erez Kaminski
and
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March 19, 2026
May 12, 2023
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