Claude Cowork Plugin
🏥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
Click a command to copy it. To run it in the Claude app, type it and pick it from the menu that appears; pasting it sends plain text instead of running it.
/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.
Press Enter to copy this example prompt.Check whether extending our diabetic-retinopathy AI to a new fundus camera model stays inside our existing PCCP envelope.
Press Enter to copy this example prompt.Triage three adverse events on our AI-enabled ECG device for 21 CFR 803 reportability and draft any required MedWatch 3500A.
Press Enter to copy this example prompt.Evaluate training-data diversity for our sepsis prediction model against the intended-use population and flag bias gaps.
Press Enter to copy this example prompt.Install this plugin
Claude desktop app (Cowork)
- Click Customize in the left sidebar, open the Plugins tab, then Add → Add marketplace → Add from a repository.
- Paste
alexclowe/awesome-claude-cowork-pluginsand click Sync. - Under Discover, click Add next to Healthcare Compliance Officer.
Requires a paid Claude plan. Anthropic is merging Cowork into the main Claude app; this path is the same either way.
Claude Code (terminal)
/plugin marketplace add alexclowe/awesome-claude-cowork-plugins/plugin install healthcare-compliance-officer@awesome-claude-cowork-pluginsRun inside Claude Code. 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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