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fda-consultant-specialist
Use for FDA medical device questions: 510(k) vs De Novo vs PMA, predicates and substantial equivalence, QMSR (21 CFR 820), HIPAA or device cybersecurity. Runs fda_submission_tracker.py, qsr_compliance_checker.py and hipaa_risk_assessment.py.
ra-qm-team/skills/fda-consultant-specialist/SKILL.md
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SKILL.mdcore · 11,910 bytesSKILL.mdcore · 11,910 bytesreferences/device_cybersecurity_guidance.mddoc · 18,342 bytesreferences/fda_capa_requirements.mddoc · 22,415 bytesreferences/fda_submission_guide.mddoc · 11,793 bytesreferences/hipaa_compliance_framework.mddoc · 19,254 bytesreferences/qsr_compliance_requirements.mddoc · 21,839 bytesscripts/fda_submission_tracker.pyruns · 19,656 bytesscripts/hipaa_risk_assessment.pyruns · 23,184 bytesscripts/qsr_compliance_checker.pyruns · 27,195 bytes
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# FDA Consultant Specialist
FDA regulatory consulting for medical device manufacturers covering submission pathways, the Quality Management System Regulation (QMSR, 21 CFR Part 820 — formerly the QSR), HIPAA compliance, and device cybersecurity requirements.
## Table of Contents
- [FDA Pathway Selection](#fda-pathway-selection)
- [510(k) Submission Process](#510k-submission-process)
- [QMSR Compliance (formerly QSR)](#qmsr-compliance-formerly-qsr)
- [HIPAA for Medical Devices](#hipaa-for-medical-devices)
- [Device Cybersecurity](#device-cybersecurity)
- [Resources](#resources)
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