How does this skill help with 510(k) submissions?

It provides a structured workflow, checklists for required sections under 21 CFR 807.87, and scripts to track milestones and avoid common Refuse to Accept (RTA) issues.

Does it address medical device cybersecurity?

Absolutely. It covers FDA premarket requirements, including threat modeling, SBOM generation, and vulnerability disclosure planning for connected devices.

Can it help with Quality System Regulation (QSR) audits?

Yes, it includes a compliance checker script and detailed guides for implementing 21 CFR 820 subsystems like Design Controls and CAPA.

Is this skill useful for Software as a Medical Device (SaMD)?

Yes, it specifically addresses SaMD concerns such as HIPAA technical safeguards and the unique cybersecurity challenges of connected healthcare software.

FDA Consultant Specialist

Name: FDA Consultant Specialist
Author: oabdelmaksoud

byoabdelmaksoud

0•

学習とドキュメンテーション

Provides expert regulatory guidance for FDA medical device submissions, quality system compliance, and healthcare data security standards.

This Claude Code skill acts as a specialized virtual consultant for medical device manufacturers navigating the complex FDA regulatory landscape. It offers comprehensive support for selecting submission pathways like 510(k), PMA, or De Novo, while providing actionable frameworks for 21 CFR 820 Quality System Regulation (QSR) compliance. Beyond submissions, it integrates HIPAA assessment tools and medical device cybersecurity guidance, helping teams build safer, compliant products through automated tracking scripts and detailed implementation checklists for Software as a Medical Device (SaMD).

主な機能

010 GitHub stars

02Comprehensive 21 CFR 820 (QSR) compliance and CAPA guidance

03Automated FDA submission pathway decision framework

04Detailed 510(k) submission workflow and RTA issue prevention

05HIPAA technical and administrative safeguard assessment

06Medical device cybersecurity threat modeling and SBOM support

ユースケース

01Auditing existing software projects for 21 CFR 820 quality standards or HIPAA security compliance.

02Preparing structured documentation for a 510(k) submission, including substantial equivalence comparisons.

03Determining the correct regulatory pathway for a new medical device or SaMD based on risk and predicates.

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

主な機能

010 GitHub stars

02Comprehensive 21 CFR 820 (QSR) compliance and CAPA guidance

03Automated FDA submission pathway decision framework

04Detailed 510(k) submission workflow and RTA issue prevention

05HIPAA technical and administrative safeguard assessment

06Medical device cybersecurity threat modeling and SBOM support

ユースケース

01Auditing existing software projects for 21 CFR 820 quality standards or HIPAA security compliance.

02Preparing structured documentation for a 510(k) submission, including substantial equivalence comparisons.

03Determining the correct regulatory pathway for a new medical device or SaMD based on risk and predicates.