Regulatory Intelligence Knowledge Hub

Insights for Medical Device Professionals

Practical PMS guidance for FDA and Health Canada first — with selected global reference content where useful. Written from the RA/QA perspective.

1 articles|4-level explanations

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Q&AFebruary 8, 20261 min read

What Is External Post-Market Surveillance (PMS) and Why Does It Matter?

External PMS means monitoring publicly available regulatory signals for events related to your device. Here is what the standards require and how to build an audit-ready evidence system.

EU MDR FDAexternal-PMSISO 14971

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