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.

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Healthcare / Life Sciences

Discrete, Continuous

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Independent review

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