fda-consultant-specialist
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, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
87
1.07x
Quality
70%
Does it follow best practices?
Impact
99%
1.07xAverage score across 6 eval scenarios
Securityby
Passed
No known issues
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npx tessl skill review --optimize ./ra-qm-team/fda-consultant-specialist/SKILL.mdNo security issues found
Scanned
- Repository
- alirezarezvani/claude-skills
- Commit
967fe01
- Audited
- Security analysis
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