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QSR + GMLP Documentation Gap Audit
Describe the device, intended use, classification/path, and current documentation state. Get a QSR Subpart map (Design Controls, Production, Records, etc.), GMLP alignment notes against the 10 guiding principles, and a P0/P1/P2 ranked gap report with citation, expected documentation, recommended next step, and owner.
✓ Cybersecurity (premarket + post-market) flagged separately✓ Subgroup performance and intended-use-population representativeness called out✓ PCCP readiness assessment included
Results in ~45 seconds · Saves ~2 days per device