GxPlex

Verification: verified · Subject (as stated): software

4 of 86 tracked instruments.

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

Verification ● verified 4 (active — select again to clear) ◐ tool-read 2 ▨ frozen 3
Subject (as stated) no self-stated subject 8 artificial intelligence 7 software 4 (active — select again to clear) medical devices 3 security 5 computerised systems 2 manufacturing 3 risk management 2
+15 more data integrity 1 information security 3 quality management 1 trustworthiness 1 validation 1 clinical 2 cybersecurity 1 electronic records 1 electronic signatures 1 good manufacturing practice 1 machine learning 2 computer software 1 data quality 1 governance 1 in vitro diagnostic 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 4 of 86 instruments. Clear all filters

Verification: verified · Subject (as stated): software — 4 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 CDRH AI/ML US Food and Drug Administration US draft — recorded as draft against the primary source verified 2026-07-30 — link (opens in new tab) · retrieved
FDA CSA US Food and Drug Administration US final verified 2026-07-30 — link (opens in new tab) · retrieved
FDA PCCP US Food and Drug Administration US final verified 2026-07-28 — link (opens in new tab) · retrieved
MHRA AI Medicines and Healthcare products Regulatory Agency UK final verified 2026-07-30 — link (opens in new tab) · retrieved

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