fda-consultant-specialist
fda-consultant-specialist is a Privacy & regulatory compliance skill for AI agents, published by borghei in the Claude-Skills repository on GitHub. Skillspace rates fda-consultant-specialist D (68/100) and it passed the safety scan; the rating is based on static analysis only.
FDA regulatory consultant for medical device companies, covering 510(k)/PMA/De Novo pathways, QSR (21 CFR 820), HIPAA, and device cybersecurity. Use for FDA submissions, predicate and substantial-equivalence analysis, and premarket strategy.
- Grade
- D
- Quality
- 68 / 100
- Safety
- Passed
- GitHub stars
- 372
Unproven: rated by static analysis only, not yet compared head-to-head.
This rating describes the version of the repository we crawled; it may have changed since, so go by its current files.
Our review
- Architecture
- 66 / 100
- Maturity
- Packaged: licensed, with a version or references
- Security scan
- No issues found
- License
- Not declared. Check the repository before reusing it.
- Adoption
- Adopted by 0 other repositories, in 1 collections
Not checked yet
- Not judged on the rubric yet (not a contender in its category)
- No blind task eval yet
- Scope (portable / vendor / repo-internal) not assessed; only the top of each category is read for scope
- Sibling files (scripts, references) not fetched; security scan covers SKILL.md only
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