Does this skill help with 510(k) clearance?

Yes, it provides a comprehensive framework for predicate device research, substantial equivalence comparison, and submission preparation.

How does this skill support FDA inspection readiness?

It offers inspection protocols, quality system gap analysis, and mock inspection simulations to ensure compliance with QSR standards.

What help does it provide for Software as a Medical Device (SaMD)?

It covers software risk categorization, lifecycle documentation per FDA guidance, and essential cybersecurity controls.

Can it assist with HIPAA compliance for cloud-based medical software?

Absolutely. It includes guidance on technical safeguards, PHI data flow mapping, and business associate agreement requirements.

FDA Regulatory Consultant

Name: FDA Regulatory Consultant
Author: alirezarezvani

byalirezarezvani

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1,039

Security & Testing

Navigates complex FDA regulatory pathways, QSR compliance, and HIPAA requirements for medical device and healthcare software development.

About

The FDA Consultant Specialist skill equips Claude with the expertise of a senior regulatory affairs professional to assist medical device companies in achieving market clearance. It provides detailed guidance on selecting submission pathways like 510(k), PMA, or De Novo, while ensuring compliance with Quality System Regulations (21 CFR 820) and HIPAA data protection standards. This skill is essential for MedTech teams managing the lifecycle of Software as a Medical Device (SaMD), implementing cybersecurity safeguards, and preparing for rigorous FDA inspections or audits.

Key Features

1,039 GitHub stars
HIPAA risk assessment and PHI safeguard implementation
Medical device cybersecurity guidance and SBOM management
FDA inspection readiness and warning letter response planning
FDA pathway selection and strategy (510(k), PMA, De Novo)
QSR 21 CFR 820 compliance framework and documentation

Use Cases

Drafting QSR-compliant design controls and CAPA documentation for quality management.
Conducting HIPAA technical safeguard evaluations for connected healthcare platforms.
Developing a regulatory strategy for new Software as a Medical Device (SaMD) products.

About

Key Features

1,039 GitHub stars
HIPAA risk assessment and PHI safeguard implementation
Medical device cybersecurity guidance and SBOM management
FDA inspection readiness and warning letter response planning
FDA pathway selection and strategy (510(k), PMA, De Novo)
QSR 21 CFR 820 compliance framework and documentation

Use Cases

Drafting QSR-compliant design controls and CAPA documentation for quality management.
Conducting HIPAA technical safeguard evaluations for connected healthcare platforms.
Developing a regulatory strategy for new Software as a Medical Device (SaMD) products.