attorney
claudeDraft memos, demand letters, contracts, motions, deposition summaries, case timelines, and AI risk memos
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claude
healthcare-compliance-officer
Validate AI medical devices, manage PCCPs, monitor adverse events, and stay aligned with FDA QSR
/
Plugin healthcare-compliance-officer from marketplace awesome-claude-cowork-plugins in alexclowe/awesome-claude-cowork-plugins. Commands read from the repo's manifest — 1 month ago.
What it installs
Skills (2)
clinical-evidence-mapperMap clinical study data to FDA Substantial Equivalence and clinical performance criteria for AI-enabled medical devices
fda-classification-advisorDetermine the appropriate FDA premarket pathway for an AI-enabled medical device based on intended use and predicate landscape
Slash commands (4)
/healthcare-compliance-officer:assess-data-qualityEvaluate training-data diversity for the intended-use population and flag bias / robustness gaps
/healthcare-compliance-officer:manage-pccpDraft or audit a Predetermined Change Control Plan and check whether a proposed modification stays in scope
/healthcare-compliance-officer:monitor-adverse-eventsIngest adverse event descriptions, assess causation, decide if FDA MedWatch reporting is required, and draft the report
/healthcare-compliance-officer:validate-ai-deviceAssess clinical validation for an AI-enabled medical device against QSR (21 CFR 820) and generate a documentation gap report
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