Stats
Actions
Available In
Tags
Plugin
healthcare-compliance-officer
Manage FDA compliance for AI-enabled medical devices—validate clinical performance against QSR, determine regulatory pathways (510k, De Novo, PMA), draft Predetermined Change Control Plans (PCCPs), and triage adverse events for MedWatch reporting.
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
Added
Available In
Tags
'%20stop-opacity%3D'0.16'%2F%3E%3Cstop%20offset%3D'1'%20stop-color%3D'rgb(200%2C90%2C60)'%20stop-opacity%3D'0.03'%2F%3E%3C%2FlinearGradient%3E%3C%2Fdefs%3E%3Crect%20width%3D'320'%20height%3D'200'%20fill%3D'url(%23g)'%2F%3E%3Ccircle%20cx%3D'250'%20cy%3D'56'%20r%3D'92'%20fill%3D'rgb(200%2C90%2C60)'%20fill-opacity%3D'0.06'%2F%3E%3Ccircle%20cx%3D'64'%20cy%3D'172'%20r%3D'58'%20fill%3D'rgb(200%2C90%2C60)'%20fill-opacity%3D'0.05'%2F%3E%3C%2Fsvg%3E)
