REG-FDA820
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).
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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 meddev-skills-reg-fda820Setup by platform
Install
One-click setup for your editorRun in your project root
npx @skills-hub-ai/cli install meddev-skills-reg-fda820 --target claude-codeInstructions
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Frequently asked questions about REG-FDA820
What does the REG-FDA820 skill do?
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). 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-FDA820 skill?
Run `npx @skills-hub-ai/cli install meddev-skills-reg-fda820` from your terminal. The CLI writes the SKILL.md to the correct location for your AI tool (e.g. ~/.claude/skills/meddev-skills-reg-fda820/ 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-FDA820 work with?
REG-FDA820 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-FDA820 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-FDA820 after installing it?
In Claude Code, type `/meddev-skills-reg-fda820` (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-FDA820 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.