fda-consultant-specialist
climaprime25/claude-skillsFDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by…
Scores out of 100 · grade B+
2026-08-22Works
40% of the score100/100
- Loads cleanly: valid frontmatter, required fields present, no dangling references.
Maintained
25% of the score94/100
- no commits in the last 12 weeks
- no license file
Adopted
20% of the score0/100
- No install or star signal yet.
Documented
15% of the score100/100
- 1,540 words with worked examples.
- Ships 8 bundled files.
Install
npx skills add climaprime25/claude-skills/fda-consultant-specialistWhat the check found
| Finding | What it means |
|---|---|
| No license | The repository ships no license file, so the reuse terms are unclear. |
What it says it does
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
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|---|---|---|---|---|---|
| mdr-745-specialistclimaprime25/claude-skills | No license | Skill | no signal | 7 days ago | |
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| agenthubclimaprime25/claude-skills | No license | Skill | no signal | 3 days ago | |
| agile-product-ownerclimaprime25/claude-skills | No license | Skill | no signal | 3 days ago |
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