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The Compliance Matrix Isn’t Optional – Building a Defensible List of Applicable Requirements Theme:  ISO 13485:2016 §4.2.1, §4.1.6 · MDR Annex II §4 · IVDR Annex II §4 · PRRC Oversight · FDA QMSR Alignment Introduction Most regulatory teams can show you a list of “applicable regulations and standards.”Far fewer can show how  that list was built, why  each item is included or excluded, and what process  keeps it current. In 2025, that’s a problem — and auditors know it. The r

This edition provides a structured framework to build an audit-ready justification system that aligns technical, clinical, and regulatory evidence into a coherent and defensible chain of reasoning.

Theme: ISO 13485 §4.1.3 • MDR Article 10.9 • Annex II Section 4 This Month’s Focus Traceability is not just about knowing what changed....

System-level execution for MDR, IVDR, and ISO 13485 §4.1.3 You’re likely knee-deep in technical documentation updates, legacy device...