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.
Packaged view
This page reorganizes the original catalog entry around fit, installability, and workflow context first. The original raw source lives below.
Install command
npx @skill-hub/cli install openclaw-skills-fda-consultant-specialist
Repository
Skill path: skills/alirezarezvani/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.
Open repositoryBest for
Primary workflow: Ship Full Stack.
Technical facets: Full Stack.
Target audience: Development teams looking for install-ready agent workflows..
License: Unknown.
Original source
Catalog source: SkillHub Club.
Repository owner: openclaw.
This is still a mirrored public skill entry. Review the repository before installing into production workflows.
What it helps with
- Install fda-consultant-specialist into Claude Code, Codex CLI, Gemini CLI, or OpenCode workflows
- Review https://github.com/openclaw/skills before adding fda-consultant-specialist to shared team environments
- Use fda-consultant-specialist for development workflows
Works across
Favorites: 0.
Sub-skills: 0.
Aggregator: No.