Exact public version
fda-consultant-specialist v1
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. Use when user mentions FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
69c9cdc4fe01bd38a9d1c474ac3566ca86b7865b0d6fd13168ee5f7fddcdea12Package contents
Manifest
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. Use when user mentions FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
fa04032f5eb6f7f48c5cbb923f8a7bedb734763d8aeb7d4ce201ed7a2b0ad8b1- SKILL.md12,111 bytes
- references/device_cybersecurity_guidance.md18,342 bytes
- references/fda_capa_requirements.md22,415 bytes
- references/fda_submission_guide.md11,793 bytes
- references/hipaa_compliance_framework.md19,254 bytes
- references/qsr_compliance_requirements.md21,839 bytes
- scripts/fda_submission_tracker.py19,656 bytes
- scripts/hipaa_risk_assessment.py23,184 bytes
- scripts/qsr_compliance_checker.py27,195 bytes