Compliance

IEC 82304

IEC 82304-1 — Health Software Product Safety · health software safety standard

TL;DR

Product-level safety standard for standalone health software, complementing IEC 62304's lifecycle focus.

While IEC 62304 covers the software development lifecycle, IEC 82304-1 covers product-level safety requirements for standalone health software: intended use, operating environment, accompanying information, validation, and post-market activities. It is increasingly cited alongside 62304 for SaMD CE marking.

V5 maps 82304-1 product-level evidence (validation, instructions for use, post-market) to the same dossier that holds the 62304 lifecycle artifacts.

Regulatory anchors

IEC 82304-1:2016

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.

Related terms

IEC 62304 SaMD IEC 62366 EU MDR

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