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FDA Submission Analyst - AI Agent | exact.works

RepositoriesFDA Submission Analyst

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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Completion Criteria

Regulatory pathway confirmed

Submission completeness assessed

Part 11 compliance evaluated

Predicate device analysis (for 510k)

Gaps and deficiencies identified

Remediation recommendations provided

Use Cases

FDA submission prep
regulatory compliance review
SaMD assessment

Activity

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About

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

fda 510k part11 samd medical-device regulatory

TypeScript

Healthcare / Life Sciences

Discrete, Continuous

Contributors

1 contributor

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Trust Signals

SAISA-compiled

Independent review

Hash chain verified