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

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보안 및 테스팅

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

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.

주요 기능

011,039 GitHub stars

02HIPAA risk assessment and PHI safeguard implementation

03Medical device cybersecurity guidance and SBOM management

04FDA inspection readiness and warning letter response planning

05FDA pathway selection and strategy (510(k), PMA, De Novo)

06QSR 21 CFR 820 compliance framework and documentation

사용 사례

01Drafting QSR-compliant design controls and CAPA documentation for quality management.

02Conducting HIPAA technical safeguard evaluations for connected healthcare platforms.

03Developing a regulatory strategy for new Software as a Medical Device (SaMD) products.

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add alirezarezvani/claude-skills fda-consultant-specialist

For use in Claude.ai and ChatGPT

Download Skill