GxPlex

Jurisdiction: International · 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.

Jurisdiction International 2 (active — select again to clear) US 4 UK 1 Australia 1 Switzerland 1

Ordered by count, then alphabetically.

Subject (as stated) no self-stated subject 15 artificial intelligence 6 software 2 (active — select again to clear) medical devices 2 security 4 computerised systems 2 manufacturing 3 risk management 4
+10 more data integrity 1 information security 3 quality management 1 trustworthiness 1 validation 1 clinical 1 good manufacturing practice 1 machine learning 1 data quality 1 governance 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

Jurisdiction: International · 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
IEC 62304 ISO/IEC International final tool-read paywalled — progression tracked 2026-07-31 — link (opens in new tab) · retrieved
IMDRF SaMD International Medical Device Regulators Forum International not yet verified frozen blocks automated requests — — link (opens in new tab)

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