meddev-fda-820-design-controls

by Medical Device Skills

Map 21 CFR Part 820 Subpart C — Design Controls to software lifecycle work: design planning, inputs, outputs, review, verification, validation, transfer, and DHF/DMR links, including how software validation (intended use / risk controls) complements verification (requirements and specs). Includes a concise ISO 13485:2016 slice where it overlaps QMS expectations for design and risk (interpretation; align with your notified-body MDSAP scope for EU). Use when working on fda 820 design controls in medical device software.

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npx @skills-hub-ai/cli install meddev-skills-meddev-fda-820-design-controls --target claude-code

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Frequently asked questions about meddev-fda-820-design-controls

What does the meddev-fda-820-design-controls skill do?

How do I install the meddev-fda-820-design-controls skill?

Run `npx @skills-hub-ai/cli install meddev-skills-meddev-fda-820-design-controls` from your terminal. The CLI writes the SKILL.md to the correct location for your AI tool (e.g. ~/.claude/skills/meddev-skills-meddev-fda-820-design-controls/ 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 meddev-fda-820-design-controls work with?

meddev-fda-820-design-controls 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 meddev-fda-820-design-controls 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 meddev-fda-820-design-controls after installing it?

In Claude Code, type `/meddev-skills-meddev-fda-820-design-controls` (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 meddev-fda-820-design-controls 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.