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healthcare-compliance-officer
Navigate FDA premarket pathways (510k, De Novo, PMA) for AI/ML medical devices, draft and audit Predetermined Change Control Plans (PCCPs), triage adverse events for MedWatch reportability, and generate QSR clinical validation gap reports.
What's Inside
Slash Commands4
Output format
/assess-data-quality
Evaluate training-data diversity for the intended-use population and flag bias / robustness gaps
Output format
/manage-pccp
Draft or audit a Predetermined Change Control Plan and check whether a proposed modification stays in scope
Output format
/monitor-adverse-events
Ingest adverse event descriptions, assess causation, decide if FDA MedWatch reporting is required, and draft the report
Output format
/validate-ai-device
Assess clinical validation for an AI-enabled medical device against QSR (21 CFR 820) and generate a documentation gap report
Skills2
clinical-evidence-mapper
/clinical-evidence-mapper
Map clinical study data to FDA Substantial Equivalence and clinical performance criteria for AI-enabled medical devices
fda-classification-advisor
/fda-classification-advisor
Determine the appropriate FDA premarket pathway for an AI-enabled medical device based on intended use and predicate landscape
Stats
Version1.0.0
Stars13
MaintenanceExcellent
LicenseMIT
Last Commit
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