Ketryx SaMD Blog - Ketryx

Writing Code Before Design Controls is Not Only Legal, It’s the Future of Product Development

Erez Kaminski
and
Paul Jones

June 15, 2026

Why iterative, AI-assisted development is compatible with FDA rules, IEC 62304, and GPSV.

How to Create a Design and Development File for Medical Devices

Lee Chickering

April 6, 2026

Why Change Impact Assessment Is the Hidden Bottleneck in Medical Device Development

Megan Mannino

July 14, 2026

How to Validate Ketryx

Lee Chickering

June 22, 2026

Ketryx’s New Integration with Azure DevOps (ADO): End-to-End Traceability for Regulated Teams

Milan Dzenovljanovic

March 19, 2026

.svg)

Why So Many Medical Device Companies Lack Real-Time Traceability and Visibility

Jake Stowe

March 19, 2026

Modernizing the Medical Device Factory to Work With Software

Erez Kaminski

March 19, 2026

IEC 62304 & Requirements Traceability Matrix (RTM) in Jira: A Guide for Medical Device Companies

Jan Pöschko

March 19, 2025

How to generate an SBOM (Software Bill of Materials) fast

Jan Pöschko

March 26, 2026

Best Practices for Maintaining a Requirement Traceability Matrix in Agile

Jake Stowe

March 19, 2026

Three steps for traceability in medical device software development quality and compliance

Paul Jones

February 11, 2025

Why the FDA’s Most Common Warning Letter Might Surprise You

Erez Kaminski

March 26, 2026

The Ultimate Guide to Requirements Traceability Matrix (RTM)

Jake Stowe

March 26, 2026