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.
Signing
SignedSLSA L2- Signed by
- skills-hub.ai distributor
- Method
- Distributor-signed by skills-hub.aiCryptographically signed by the skills-hub.ai distributor key at publish time.
- Signed
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-lifecycleSetup by platform
Install
One-click setup for your editorRun in your project root
npx @skills-hub-ai/cli install medical-device-lifecycle --target claude-codeComposed 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
Security
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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.