How does it assist with Quality System Regulations (QSR)?

The skill provides detailed breakdowns of 21 CFR 820 requirements, including design controls (820.30), CAPA processes (820.100), and document controls.

Can this skill help with 510(k) submissions?

Yes, it provides frameworks for identifying predicate devices, comparing technological characteristics, and ensuring all required sections of the eSTAR submission are addressed.

Does it cover software as a medical device (SaMD)?

Absolutely. It specifically addresses HIPAA technical safeguards, transmission security (TLS), and FDA cybersecurity requirements for network-connected software.

What is the FDA Consultant Specialist skill?

It is a specialized capability for Claude that provides expert domain knowledge regarding medical device regulatory pathways, quality management systems, and federal compliance standards.

Is this skill useful for cybersecurity audits?

Yes, it includes guidance on threat modeling (STRIDE), Software Bill of Materials (SBOM) requirements, and coordinated vulnerability disclosure plans.

FDA Regulatory Consultant

Name: FDA Regulatory Consultant
Author: oabdelmaksoud

byoabdelmaksoud

0•

Security & Testing

Provides expert guidance on FDA medical device submissions, Quality System Regulation (QSR) compliance, HIPAA standards, and device cybersecurity.

The FDA Consultant Specialist skill transforms Claude into a specialized regulatory expert for medical device manufacturers and software developers. It offers structured frameworks for selecting FDA submission pathways like 510(k), PMA, and De Novo, while providing actionable guidance for implementing 21 CFR Part 820 Quality System Regulations. Beyond submissions, it helps users navigate complex HIPAA assessments for connected devices and provides technical cybersecurity requirements, including SBOM and threat modeling guidance. This skill is essential for maintaining compliance throughout the medical device lifecycle, from design controls to postmarket surveillance.

Key Features

01CAPA (Corrective and Preventive Action) workflow management

020 GitHub stars

03Regulatory pathway decision matrices for 510(k), PMA, and De Novo

04HIPAA technical safeguard assessments for medical software

05Cybersecurity threat modeling and SBOM formatting support

06QSR (21 CFR 820) compliance checklists and subsystem guidance

Use Cases

01Evaluating cybersecurity and HIPAA compliance for connected medical devices

02Conducting internal audits against Quality System Regulation standards

03Determining the most efficient FDA submission pathway for a new device

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add oabdelmaksoud/agention fda-consultant-specialist

For use in Claude.ai and ChatGPT

Key Features

01CAPA (Corrective and Preventive Action) workflow management

020 GitHub stars

03Regulatory pathway decision matrices for 510(k), PMA, and De Novo

04HIPAA technical safeguard assessments for medical software

05Cybersecurity threat modeling and SBOM formatting support

06QSR (21 CFR 820) compliance checklists and subsystem guidance

Use Cases

01Evaluating cybersecurity and HIPAA compliance for connected medical devices

02Conducting internal audits against Quality System Regulation standards

03Determining the most efficient FDA submission pathway for a new device

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add oabdelmaksoud/agention fda-consultant-specialist

For use in Claude.ai and ChatGPT