Healthcare Compliance Officer
Validate AI medical devices, manage PCCPs, monitor adverse events, and stay aligned with FDA QSR
The Healthcare Compliance Officer plugin helps you run FDA-regulated AI/ML device compliance under the post-market shift introduced by FDA's January 2026 guidance and the December 2024 PCCP final guidance. Every command works standalone with your input — describe the device, modification, or event and get a structured draft ready for regulatory affairs and clinical review.
Use /validate-ai-device to audit a clinical validation package against QSR (21 CFR 820) and GMLP. Use /manage-pccp to draft a Predetermined Change Control Plan or scope-check a proposed modification. Use /monitor-adverse-events to triage 21 CFR 803 reportability and draft MedWatch 3500A content. Use /assess-data-quality to evaluate training-data diversity against the intended-use population and flag bias / robustness gaps.
The plugin's skills activate automatically when relevant: FDA Classification Advisor — pick the right premarket pathway among 510(k), De Novo, PMA, and CDS carve-outs, plus Clinical Evidence Mapper — map study data to Substantial Equivalence and clinical performance criteria.
Commands
/validate-ai-deviceAssess clinical validation for an AI-enabled medical device against QSR (21 CFR 820) and generate a documentation gap report
/manage-pccpDraft or audit a Predetermined Change Control Plan and check whether a proposed modification stays in scope
/monitor-adverse-eventsIngest adverse event descriptions, assess causation, decide if FDA MedWatch reporting is required, and draft the report
/assess-data-qualityEvaluate training-data diversity for the intended-use population and flag bias / robustness gaps
Skills
Skills activate automatically when Claude Cowork detects you're working on relevant tasks — no slash command needed.
FDA Classification Advisor
Determine the appropriate FDA premarket pathway for an AI-enabled medical device based on intended use and predicate landscape
Clinical Evidence Mapper
Map clinical study data to FDA Substantial Equivalence and clinical performance criteria for AI-enabled medical devices
Usage examples
Audit our CT triage AI's validation package against QSR and GMLP and identify documentation gaps before the 510(k) submission.
Check whether extending our diabetic-retinopathy AI to a new fundus camera model stays inside our existing PCCP envelope.
Triage three adverse events on our AI-enabled ECG device for 21 CFR 803 reportability and draft any required MedWatch 3500A.
Evaluate training-data diversity for our sepsis prediction model against the intended-use population and flag bias gaps.
AI Career Lab — All AI Prompts Bundle
All eight profession-specific AI Prompts packs — 393 agentic skills total with ambient compliance guards. Runs on Claude Cowork.
Get all 8 packs for $49Install this plugin
Claude Cowork
/plugin marketplace add alexclowe/awesome-claude-cowork-plugins/plugin install healthcare-compliance-officer@awesome-claude-cowork-pluginsPaste in Claude Cowork (requires a paid Claude plan). Add the marketplace once, then install any plugin by name.
All content generated by this plugin is for drafting and informational purposes only. The healthcare compliance officer is responsible for reviewing, verifying, and customizing all outputs before professional use. This plugin does not constitute professional advice.
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