FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820)…
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substant…
Use npx skills add to install this skill into the selected agent. Phase 0 commands are generated from source rules, not verified.
npx skills add https://github.com/alirezarezvani/claude-skills/blob/main/ra-qm-team/skills/fda-consultant-specialist/SKILL.md -g -a codex -yDrop `-g` to install project-locally
Create, test, and improve skills in an eval loop.
Distill how a person thinks into a reusable skill.
Development conventions and patterns for everything-claude-code. JavaScript project with conventional commits.
| this skill · 当前fda consultant specialist | Anthropic Skill Creator | Nuwa Skill | everything-claude-code-conventions | |
|---|---|---|---|---|
| Rating · 评分 | — | 4.9 | 4.7 | — |
| Stars · 星标 | 14k | 122k | 14k | 187k |
| Risk · 风险 | Medium risk · 中风险 | Medium risk · 中风险 | Medium risk · 中风险 | Medium risk · 中风险 |
| Best for · 最适合 | 代码审查 | New skill creation | Distill how a person thinks into a reusable skill. | Development conventions and patterns for everything-claude-code. JavaScript project with conventional commits. |
| Not for · 不适合 | Workflows that require stronger human review than this catalog entry documents. | One-off task automation | Workflows that require stronger human review than this catalog entry documents. | Workflows that require stronger human review than this catalog entry documents. |