exact.works / FDA Submission Analyst

Reviews FDA regulatory submissions for compliance. Covers 510(k), 21 CFR Part 11, and software as a medical device (SaMD) requirements.

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Regulatory pathway confirmed

Submission completeness assessed

Part 11 compliance evaluated

Predicate device analysis (for 510k)

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Reviews FDA regulatory submissions for compliance. Covers 510(k), 21 CFR Part 11, and software as a medical device (SaMD) requirements.

TypeScript

Healthcare / Life Sciences

Discrete, Continuous

1 contributor

SAISA-Exacted

Independent review

Hash chain verified