Medical Device Agent Skills

imageSkills imageLicense imageIEC 62304

Modular "skill" files for AI coding agents working on medical device software. Each skill captures scoped, actionable guidance (requirements, patterns, anti-patterns, verification) to help agents produce safer, more compliant code without replacing human regulatory review.

What This Repo Is

• Curated guidance aligned to medical device standards (IEC 62304, ISO 14971, FDA, EU MDR)
• Machine-readable and agent-friendly (consistent schema, metadata, prerequisites)
• Code-focused with patterns, anti-patterns, and verification checklists

Target Audience

• Device Engineers — Embedded, connectivity, cloud developers building medical software
• QA/RA Engineers — Quality and regulatory pros collaborating with AI-assisted development
• Tool Builders — Integrating domain skills into Copilot, Claude, Cursor, or custom agents

Install

Choose either the shared installer (individual skills) or a native plugin (the full collection). Avoid installing both, which can show duplicate skills.

One command for Claude Code, Codex, and Cursor

Requires Node.js and npm. Run from the project where you want the skills:

npx skills add AminAlam/meddev-agent-skills -a claude-code -a codex -a cursor

Select skills interactively. Add -g to install across your projects. Preview available skills:

npx skills add AminAlam/meddev-agent-skills --list

For example, install the lifecycle hub and its risk-management prerequisite:

npx skills add AminAlam/meddev-agent-skills --skill meddev-iec-62304 --skill meddev-iso-14971 -a claude-code -a codex -a cursor

Claude Code plugin

Run inside Claude Code:

/plugin marketplace add AminAlam/meddev-agent-skills
/plugin install meddev-agent-skills@meddev-agent-skills

Restart the session if the skills do not appear. Invoke a skill with /meddev-agent-skills:meddev-iec-62304 or describe the relevant task.

Codex plugin

With a current Codex CLI:

codex plugin marketplace add AminAlam/meddev-agent-skills
codex plugin add meddev-agent-skills@meddev-agent-skills

Restart Codex after installation. In desktop versions with a Plugins directory, select Medical Device Agent Skills as the marketplace source and install the plugin. If your version does not provide these plugin commands, use the shared installer above. Invoke an installed skill with $meddev-iec-62304 or describe the relevant task.

Cursor plugin

Open Customize → From GitHub Repository and enter:

https://github.com/AminAlam/meddev-agent-skills

Install meddev-agent-skills from the imported marketplace. The skills appear in Customize. If your Cursor version does not offer repository import, use the shared installer above.

Use and update

Ask, for example: “Use the IEC 62304 lifecycle skill to review our software development plan.” Skills are selected by their descriptions; installing the collection does not load every skill body into each conversation.

The full plugin includes all prerequisites. When installing selected skills, also select the prerequisites listed in each skill's metadata.prerequisites; native tools do not automatically resolve those custom IDs. The skill catalog maps IDs to installable names.

Update shared-installer skills with npx skills update. For native plugins, refresh the marketplace and use the tool's plugin update controls. Maintainers should increment the plugin version when releasing changes.

Sources: Skills CLI, Claude Code marketplaces, Codex plugins, Cursor repository installation.

Quick Start

1. Install relevant skills or the full plugin using one route above.
2. Select guidance by domain, jurisdiction, and safety class.
3. Follow the verification checklist when writing or reviewing code.
4. Maintain traceability: Requirements → Design → Code → Tests.
5. Reference examples/ for patterns with annotations.

For custom integrations and metadata filtering, see Agent Integration. For publication and local checks, see Distribution.

Skill Index

Regulatory

Architecture

Firmware

Connectivity

Security

Testing

Documentation

Data

CI/CD

Disclaimer

These skills supplement, not replace, reading the actual standards and guidance. They paraphrase obligations by clause reference only and do not reproduce copyrighted standard text. Obtain and use your own licensed copies of IEC, ISO, FDA, and EU documents for authoritative review. Interpretations are noted; always verify with official documents and your QA/RA sign-off. Jurisdictional differences (FDA vs EU MDR) are called out where relevant.

Contributing

See CONTRIBUTING.md for how to propose or update skills. Quality requires citations to standards, runnable code examples, and verification criteria. Regulatory/domain expert review is required for merges.

License

MIT License — see LICENSE.