FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device cybersecurity.
Full prompt is for subscribers
Get instant access to this and every other prompt in the library.
Unlock for $14.89/monthYou're seeing the public preview
Subscribe to unlock the full prompt, recommended model, and usage notes for every entry in the library.
Get full access — $14.89/month