Stats
Actions
Available In
Tags
Help us improve
Share bugs, ideas, or general feedback.
Plugin
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.
$
npx claudepluginhub alexclowe/awesome-claude-cowork-plugins --plugin healthcare-compliance-officerPopularity
Stars
Med: 0·Avg: 279
Installs
Med: 0·Avg: 1
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
Help us improve
Share bugs, ideas, or general feedback.
