Compliance

IMDRF Essential Principles

essential principles of safety and performance · ep

TL;DR

Globally harmonised safety and performance requirements every medical device must meet, mapped to standards as the technical evidence.

The IMDRF Essential Principles of Safety and Performance define the high-level safety/performance requirements every device must meet, regardless of jurisdiction. Manufacturers map each principle to recognised consensus standards (ISO 13485, ISO 14971, IEC 60601, etc.) inside the technical file / 510(k) submission.

V5 maintains the EP-to-evidence map alongside design controls so every submission shows the same chain from principle to test report.

Regulatory anchors

IMDRF GRRP WG/N47
EU MDR Annex I
21 CFR 820

Industries that live with this

Medical Devices

How V5 handles it

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

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