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
How to use the Adaptyv Bio Foundry API and Python SDK for protein experiment design, submission, and results retrieval.
Structured manuscript/grant review with checklist-based evaluation. Use when writing formal peer reviews with specific…
Query the Cancer Dependency Map (DepMap) for cancer cell line gene dependency scores (CRISPR Chronos), drug sensitivity…
| this skill · 当前fda consultant specialist | adaptyv | peer review | depmap | |
|---|---|---|---|---|
| Rating · 评分 | — | — | — | — |
| Stars · 星标 | 14k | 21k | 21k | 21k |
| 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 | How to use the Adaptyv Bio Foundry API and Python SDK for protein experiment design, submission, and results retrieval. | Structured manuscript/grant review with checklist-based evaluation. Use when writing formal peer reviews with specific… | Query the Cancer Dependency Map (DepMap) for cancer cell line gene dependency scores (CRISPR Chronos), drug sensitivity… |
| Not for · 不适合 | Workflows that require stronger human review than this catalog entry documents. | Workflows that require stronger human review than this catalog entry documents. | Workflows that require stronger human review than this catalog entry documents. | Workflows that require stronger human review than this catalog entry documents. |