Does it provide HIPAA implementation tools?

Yes, it offers scripts and checklists for assessing technical, physical, and administrative safeguards required for devices handling Protected Health Information (PHI).

Can this help with 21 CFR 820 compliance?

Yes, it provides detailed guidance on Quality System Regulation (QSR), including design controls, CAPA processes, and Device Master Record (DMR) requirements.

What FDA pathways does this skill support?

It supports Traditional, Special, and Abbreviated 510(k) submissions, as well as De Novo and PMA pathways, providing decision matrices and timeline estimates for each.

How does it handle medical device cybersecurity?

The skill includes frameworks for threat modeling (STRIDE), SBOM creation, and meeting FDA premarket requirements for connected medical devices.

FDA Regulatory Consultant

Name: FDA Regulatory Consultant
Author: oabdelmaksoud

byoabdelmaksoud

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Security & Testing

Provides expert guidance on FDA submission pathways, QSR compliance, HIPAA safeguards, and medical device cybersecurity requirements.

This specialist skill empowers Claude to act as a regulatory consultant for medical device manufacturers, offering comprehensive support for FDA 510(k), PMA, and De Novo submission pathways. It facilitates compliance with Quality System Regulation (21 CFR Part 820) through structured design control workflows and CAPA processes, while also addressing critical modern requirements like HIPAA technical safeguards and premarket cybersecurity threat modeling. Whether you are identifying predicate devices or preparing software documentation for eSTAR submissions, this skill ensures your development lifecycle aligns with current CDRH standards.

Key Features

01QSR (21 CFR 820) compliance assessment and design control workflows

02Medical device cybersecurity threat modeling and SBOM preparation

03Automated submission tracking and compliance checking scripts

04HIPAA technical safeguard audits for medical device software

05Guided FDA regulatory pathway selection for 510(k), PMA, and De Novo

060 GitHub stars

Use Cases

01Implementing a 21 CFR 820 compliant design control process for software as a medical device (SaMD).

02Performing a HIPAA risk assessment and cybersecurity audit for a cloud-connected healthcare application.

03Determining the correct FDA submission type and identifying predicate devices for a new medical device.

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add oabdelmaksoud/superclaw fda-consultant-specialist

For use in Claude.ai and ChatGPT

Key Features

01QSR (21 CFR 820) compliance assessment and design control workflows

02Medical device cybersecurity threat modeling and SBOM preparation

03Automated submission tracking and compliance checking scripts

04HIPAA technical safeguard audits for medical device software

05Guided FDA regulatory pathway selection for 510(k), PMA, and De Novo

060 GitHub stars

Use Cases

01Implementing a 21 CFR 820 compliant design control process for software as a medical device (SaMD).

02Performing a HIPAA risk assessment and cybersecurity audit for a cloud-connected healthcare application.

03Determining the correct FDA submission type and identifying predicate devices for a new medical device.