regulatory-affairs-head
regulatory-affairs-head is a Medical documentation & coding skill for AI agents, published by borghei in the Claude-Skills repository on GitHub. Skillspace rates regulatory-affairs-head C (75/100) and it passed the safety scan; the rating is based on static analysis only.
Senior Regulatory Affairs Manager for HealthTech and MedTech. Use for regulatory strategy, FDA 510(k)/PMA/De Novo submissions, EU MDR CE marking, global market access, and regulatory intelligence.
- Grade
- C
- Quality
- 75 / 100
- Safety
- Passed
- GitHub stars
- 372
Unproven: rated by static analysis only, not yet compared head-to-head.
Our two independent classifiers differ on this skill's category, so treat the placement as provisional.
This rating describes the version of the repository we crawled; it may have changed since, so go by its current files.
Our review
- Architecture
- 78 / 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
- Scope
- Portable: works in any project. General medical-device regulatory affairs strategy, any organisation
Not checked yet
- Not judged on the rubric yet (not a contender in its category)
- No blind task eval yet
- Sibling files (scripts, references) not fetched; security scan covers SKILL.md only
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