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ComboComposition

Medical Device Software Lifecycle

Full IEC 62304 lifecycle for medical device software. Regulatory landscape, EU MDR, QMS setup, risk analysis, cybersecurity review, HIPAA, verification testing, and submission documentation.

v1.0.0New
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SignedSLSA L2
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skills-hub.ai distributor
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Distributor-signed by skills-hub.aiCryptographically signed by the skills-hub.ai distributor key at publish time.
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Install this skill

Run this command in your terminal. No account required — it auto-detects your AI tool and installs the skill file.

npx @skills-hub-ai/cli install medical-device-lifecycle
Or download directly:
Browse all CLI commands →

Setup by platform

Claude Code

~/.claude/skills/<skill>/SKILL.md

Setup guide →

Cursor

~/.cursor/skills/<skill>/SKILL.md

Setup guide →

Codex CLI

~/.codex/skills/<skill>/SKILL.md, or reference via codex.md instructions file

Setup guide →

Install

One-click setup for your editor

Run in your project root

npx @skills-hub-ai/cli install medical-device-lifecycle --target claude-code

Composed Skills

Full IEC 62304 lifecycle for medical device software. Regulatory landscape, EU MDR, QMS setup, risk analysis, cybersecurity review, HIPAA, verification testing, and submission documentation.

Instructions

This skill doesn’t include stateful context yet, instructions only. Learn about stateful skills.

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Frequently asked questions about Medical Device Software Lifecycle

What does the Medical Device Software Lifecycle skill do?

Full IEC 62304 lifecycle for medical device software. Regulatory landscape, EU MDR, QMS setup, risk analysis, cybersecurity review, HIPAA, verification testing, and submission documentation. It's a reusable SKILL.md instruction set that loads into your AI coding assistant on demand, no prompt engineering, no copy-pasting every session.

How do I install the Medical Device Software Lifecycle skill?

Run `npx @skills-hub-ai/cli install medical-device-lifecycle` from your terminal. The CLI writes the SKILL.md to the correct location for your AI tool (e.g. ~/.claude/skills/medical-device-lifecycle/ for Claude Code or ~/.cursor/skills/ for Cursor with --target cursor) and adds it to your project's .skills.json lockfile.

Which AI tools does Medical Device Software Lifecycle work with?

Medical Device Software Lifecycle runs in Claude Code, Cursor, Codex CLI. It follows the open Agent Skills standard (SKILL.md), so the same skill works in every supported tool without modification.

Is the Medical Device Software Lifecycle skill free?

Yes. Every skill on skills-hub.ai is free and open-source. There are no premium tiers, paywalls, or usage limits. You only pay for whatever AI assistant you're already using.

How do I use Medical Device Software Lifecycle after installing it?

In Claude Code, type `/medical-device-lifecycle` (or whatever slash command the skill registers) and the AI follows the skill's instructions immediately. You can also reference it by name in natural language, your AI loads the skill into context when relevant.

Can I share the Medical Device Software Lifecycle skill with my team?

Yes. Commit your project's .skills.json lockfile and teammates run `npx @skills-hub-ai/cli install` (no args) to install every skill at the exact version you pinned. Organization-scoped installs work via skills-hub.ai organizations.