How to Install the Healthcare Compliance Officer Claude Plugin (Cowork & Code)

Don't want to install anything? You don't have to. The free web tools for healthcare compliance officers on The AI Career Lab give you the same pre-built workflows in your browser — five runs a day on a free account, no terminal, no install. Create a free account if you'd rather skip straight to the tools.

The Healthcare Compliance Officer Claude plugin from The AI Career Lab is the fastest way to turn Claude into a medical-device-compliance-aware co-worker. It bundles 4 pre-built slash commands and 2 auto-activating skills that already know what working healthcare compliance officers actually do — QSR + GMLP documentation gap audits, PCCP scope assessments under the December 2024 final guidance, MedWatch reportability triage, and 510(k) Substantial Equivalence evidence mapping.

Every output from this plugin is framed as preparatory analysis for qualified personnel. No tool in this plugin produces a reportability determination, a Substantial Equivalence argument, or a submission-pathway conclusion. The MDR coordinator decides reportability. Regulatory affairs determines submission pathway and builds SE arguments. The plugin prepares the analysis those determinations are made from.

The plugin works in both runtimes Claude offers:

• Claude Cowork — the chat product at claude.ai. The easiest path. Requires a paid Claude plan (Pro, Max, Team, or Enterprise).
• Claude Code — the terminal CLI. Particularly useful for healthcare compliance officers since Claude Code can read your Design History File documents, V&V reports, complaint records (PHI stripped), and prior submission packages directly. Requires Node.js + npm.

What this plugin gives you

In this plugin you get:

• /qsr-gap-audit — audits AI medical device documentation against 21 CFR 820 Subparts and the 10 GMLP guiding principles with P0/P1/P2 prioritized gap report
• /pccp-scope-audit — analyzes a proposed modification against an existing PCCP per the December 2024 final guidance; produces fits/amend/new-submission recommendation
• /medwatch-triage — surfaces 21 CFR 803 reportability factors and prepares 3500A starting framework. The MDR coordinator decides reportability
• /510k-evidence-mapping — maps clinical evidence and performance data to the Substantial Equivalence framework with side-by-side predicate comparison and Q-Sub topics

Which runtime should you use?

Use Claude Cowork if:

• You already use claude.ai for chat work
• You prefer a graphical interface to a terminal
• You don't want to install anything else on your machine
• You have a paid Claude plan (Pro, Max, Team, or Enterprise)

Use Claude Code if:

• You're already in a terminal alongside your DHF documents and submission prep files
• You want Claude to read the actual documents directly (V&V reports, clinical study reports with PHI stripped, prior submissions)
• You're on a free Claude account (Claude Code plugin install does not require a paid plan)

Path A: Install in Claude Cowork (easiest, no command lines)

1. Open claude.ai in your browser and sign in.
2. Make sure you're on a paid plan (Pro, Max, Team, or Enterprise).
3. Open the plugin settings and click Add marketplace.
4. In the modal, paste this into the URL field:

alexclowe/awesome-claude-cowork-plugins

5. Click Sync. Claude Cowork pulls the marketplace catalog from the public alexclowe/awesome-claude-cowork-plugins repo.
6. Browse the marketplace. Find the Healthcare Compliance Officer plugin and click Install.

Path B: Install in Claude Code (terminal CLI, two commands)

One-time Claude Code setup

1. Install Claude Code. Open a terminal and run:

npm install -g @anthropic-ai/claude-code

2. Sign in once. Run claude in your terminal and follow the sign-in flow.

Install the plugin

Inside Claude Code, run these two commands:

/plugin marketplace add alexclowe/awesome-claude-cowork-plugins
/plugin install healthcare-compliance-officer@awesome-claude-cowork-plugins

To verify, type /help and you should see the new commands listed alongside Claude Code's built-ins.

Your first command

For most healthcare compliance officers, the highest-leverage starting point is the QSR + GMLP gap audit — every device in the portfolio benefits from a fresh gap audit:

/qsr-gap-audit

When you run it, Claude asks for the device description, intended use, classification/path, current documentation state, and known open issues. The output is a QSR Subpart map (per applicable Subpart: documentation expected, current state, likely-gap flag), GMLP alignment notes against the 10 guiding principles, and a P0/P1/P2 ranked gap report with regulatory citations and team owners.

That gap report goes to your next QA review. The P0 findings are the ones that block submission; the P1 findings need to be addressed before submission or post-market; the P2 findings are best-practice improvements.

First 4 workflows to try after install

1. QSR + GMLP gap audit — /qsr-gap-audit in the plugin, or /tools/healthcare-compliance-qsr-gap-audit on the web. Run on one device in your portfolio
2. PCCP scope audit — /pccp-scope-audit in the plugin, or /tools/healthcare-compliance-pccp-scope-audit on the web. Run on the next proposed modification
3. MedWatch reportability triage — /medwatch-triage in the plugin, or /tools/healthcare-compliance-medwatch-triage on the web. Run on the next adverse event. Strip PHI before pasting
4. 510(k) evidence mapping — /510k-evidence-mapping in the plugin, or /tools/healthcare-compliance-510k-evidence-mapping on the web. Run on the next submission you're preparing

Skills you get for free

This plugin also includes Claude Skills that activate automatically when you're working on relevant tasks:

• Escalation-First Reportability — when adverse event analysis comes up, refuses to produce confident "not reportable" conclusions. Surfaces §803.50 factors with explicit "escalate to MDR coordinator" framing. Errs toward over-escalation
• PHI-Handling Discipline — when complaint or adverse event details come up, automatically flags PHI in the input and prompts for de-identification before continuing

The first time the escalation-first skill auto-activates and refuses to give you a confident "this event is not reportable under §803.50" — instead surfacing "factors pointing toward and away from reportability; escalate to MDR coordinator" — you'll see the difference between using Claude generically and using Claude as a healthcare compliance officer's co-worker.

Where to go from here

• Claude Cowork playbook for healthcare compliance officers — the full setup guide with the five high-leverage prompt structures
• Free web tools for healthcare compliance officers — same workflows, browser-based, no install required
• Best AI Tools for Healthcare Compliance Officers in 2026 — the broader landscape including Claude, eQMS platforms, MDR systems, post-market surveillance, cybersecurity tooling
• AI for Healthcare Compliance Officers guide — the working playbook for the role

Common issues

I don't see the "Add marketplace" option in Claude Cowork. You need to be on a paid plan. If you're on a free plan, install via Claude Code instead — it's free.

The marketplace sync failed in Claude Cowork. Double-check the URL field has exactly alexclowe/awesome-claude-cowork-plugins — a GitHub owner/repo format, no https://, no trailing slash.

The slash commands aren't showing up after install. Start a new chat (Cowork) or type /help (Claude Code). If you see the built-in commands but not the new ones, the install didn't complete — re-run the install.

I want to use this without installing anything. Use the free web tools instead. Same workflows, browser-based, no install or paid plan.

Ready to try it without installing

Create your free AI Career Lab account and try the healthcare compliance officer tools today. No credit card required.

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*This article is general guidance for healthcare compliance officers. FDA regulations (21 CFR 820 / forthcoming QMSR, 21 CFR 803, the December 2024 PCCP final guidance, premarket and post-market cybersecurity guidance, GMLP guiding principles), international standards (ISO 13485, IEC 62304, ISO 14971, IEC 62366), and sector-specific obligations are evolving and jurisdiction-specific. The tools described produce preparatory analysis and starting structures — they do not produce regulatory determinations, reportability decisions, Substantial Equivalence arguments, or compliance opinions. Qualified regulatory affairs personnel, clinical leadership, the MDR coordinator, and (where appropriate) external regulatory counsel remain authoritative for those determinations. When in doubt about reportability, escalate.