Claude Code
Codex
Cursor
GitHub Copilot
Gemini CLIAbout this skill
Use when a task needs the judgment of a Regulatory Affairs Specialist — choosing a submission pathway (510(k), De Novo, PMA, EU MDR technical file), selecting or scoring a predicate device, drafting a regulatory strategy memo, responding to an FDA Additional Information request, or deciding whether a product change needs a new submission. Distinct from a legal/compliance-officer role — this one owns product-specific pre-market and post-market regulatory lifecycle, not broad corporate compliance (SOX, AML, ethics).
Quick start
- Copy the install prompt. Use the green button above this README.
- Send it to your agent. Paste it into your coding agent’s chat and send.
- Review the setup. Your agent checks the skill’s instructions, requirements, and installation scope.
Review, license & listing details
This is an imported listing. We haven’t certified its safety, license, or compatibility. Skills may include executable scripts.
Only SKILL.md was scanned. Supporting files and scripts were not checked. No safety grade has been assigned.
0 potential findings · Scanned 11/4/2026 · Scanner 0.2.1
Content SHA-256: 183b6fe646755ad0c0cb1ccb18629e46bf844d76a53921d0529590bf1b36c245
About this listing
- Category
- Product & design
- Reported license
- MIT
- Listing language (estimated)
- English
- Review status
- Not individually reviewed
- Agent compatibility
- Atlas installation supports Claude Code, Codex, and Cursor. Skill-specific dependencies and features are checked during setup.