REG-SAMD-CLIN
Guide **Software as a Medical Device (SaMD)** and **software in devices** for **clinical evaluation** expectations: intended use, SaMD category (IMDRF framework), evidence of **analytical and clinical validity** where applicable, and alignment with **EU MDR Annex XIV** clinical evaluation and **FDA** premarket clinical/benefit-risk expectations for software-driven diagnostics and monitoring.
Unsigned, install at your own risk
UnverifiedThis skill has no cryptographic signature attached. We can't verify the contents match what the publisher intended.
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 meddev-skills-reg-samd-clinSetup by platform
Install
One-click setup for your editorRun in your project root
npx @skills-hub-ai/cli install meddev-skills-reg-samd-clin --target claude-codeInstructions
Security
Reviews (0)
Frequently asked questions about REG-SAMD-CLIN
What does the REG-SAMD-CLIN skill do?
Guide **Software as a Medical Device (SaMD)** and **software in devices** for **clinical evaluation** expectations: intended use, SaMD category (IMDRF framework), evidence of **analytical and clinical validity** where applicable, and alignment with **EU MDR Annex XIV** clinical evaluation and **FDA** premarket clinical/benefit-risk expectations for software-driven diagnostics and monitoring. 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 REG-SAMD-CLIN skill?
Run `npx @skills-hub-ai/cli install meddev-skills-reg-samd-clin` from your terminal. The CLI writes the SKILL.md to the correct location for your AI tool (e.g. ~/.claude/skills/meddev-skills-reg-samd-clin/ 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 REG-SAMD-CLIN work with?
REG-SAMD-CLIN runs in Claude Code. It follows the open Agent Skills standard (SKILL.md), so the same skill works in every supported tool without modification.
Is the REG-SAMD-CLIN 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 REG-SAMD-CLIN after installing it?
In Claude Code, type `/meddev-skills-reg-samd-clin` (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 REG-SAMD-CLIN 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.