GxPlex

Verification: frozen · Subject (as stated): software

3 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 ▨ frozen 3 (active — select again to clear)
Subject (as stated) no self-stated subject 13 artificial intelligence 3 software 3 (active — select again to clear) medical devices 1 security 1 computerised systems 3 manufacturing 1 data integrity 1
+3 more quality management 1 trustworthiness 2 good manufacturing practice 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 3 of 86 instruments. Clear all filters

Verification: frozen · Subject (as stated): software — 3 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
IMDRF SaMD International Medical Device Regulators Forum International not yet verified frozen blocks automated requests — — link (opens in new tab)
Swissmedic Swissmedic Switzerland not yet verified frozen listing only — — link (opens in new tab)
TGA SaMD Therapeutic Goods Administration Australia not yet verified frozen blocks automated requests — — link (opens in new tab)

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