Software Development
FDA Consultant Specialist
The FDA Consultant Specialist guides medical device companies through the FDA regulatory process, offering expert advice on 510(k), PMA, and De Novo submissions. The specialist ensures compliance with QMSR (21 CFR 820) and ISO 13485:2016, conducts HIPAA assessments, and addresses device cybersecurity requirements. This skill benefits firms preparing pre‑market filings, evaluating predicate devices, or establishing robust quality and data‑protection systems.
- Publisher / source
- Claude Skills Collection
- Upstream record
- alirezarezvani/claude-skills
- Version
- Version 3
- Published
- Publication review
- Approved for publication
- Content fingerprint
eabacba02030144b65ca466aa7f7e91571a1275431a166f0083100153363f6e0