GxPlex

Verification: tool-read · Subject (as stated): software

2 of 86 tracked instruments.

This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.

Verification ● verified 4 ◐ tool-read 2 (active — select again to clear) ▨ frozen 3
Subject (as stated) no self-stated subject 4 artificial intelligence 1 software 2 (active — select again to clear) medical devices 2 manufacturing 1 risk management 1 data integrity 1 quality management 1
+3 more validation 2 electronic records 1 electronic signatures 1

Values match by containment: a document stating "information security" appears under "security", because one string contains the other and no mapping between words is applied.

Two facets compose at a time; the other groups return when one is cleared.

Showing 2 of 86 instruments. Clear all filters

Verification: tool-read · Subject (as stated): software — 2 instrument(s) — no change has been detected yet, so rows are alphabetical; they order by change date as soon as one is
Instrument Authority Jurisdiction Status Last verified Last changed Source
FDA software validation US Food and Drug Administration US final tool-read 2026-07-31 — link (opens in new tab) · retrieved
IEC 62304 ISO/IEC International final tool-read paywalled — progression tracked 2026-07-31 — link (opens in new tab) · retrieved

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