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.
v1.0.0New
Signing
SignedSLSA L2- Signed by
- skills-hub.ai distributor
- Method
- Distributor-signed by skills-hub.aiCryptographically signed by the skills-hub.ai distributor key at publish time.
- Signed
Install this skill
Run this command in your terminal. No account required — it auto-detects your AI tool and installs the skill file.
npx @skills-hub-ai/cli install alirezarezvani-fda-consultant-specialistOr download directly:
Browse all CLI commands →Setup by platform
Install
One-click setup for your editorRun in your project root
npx @skills-hub-ai/cli install alirezarezvani-fda-consultant-specialist --target claude-codeInstructions
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