Does it provide templates for cybersecurity requirements?

Yes, it offers frameworks for STRIDE threat modeling, Software Bill of Materials (SBOM) formats like CycloneDX, and postmarket vulnerability disclosure plans.

Is this skill useful for HIPAA compliance?

Absolutely. It identifies where HIPAA applies to medical devices and outlines the necessary administrative, physical, and technical safeguards required to protect patient data.

Can this skill help with software-specific medical regulations?

Yes, it includes guidance for IEC 62304 documentation, Software as a Medical Device (SaMD) compliance, and current FDA premarket cybersecurity expectations.

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

The skill provides detailed implementation guides for 21 CFR 820, specifically focusing on Design Controls (820.30), CAPA (820.100), and Device Master Record (DMR) requirements.

What FDA pathways does this skill support?

It supports 510(k) (Traditional, Special, Abbreviated), De Novo, and PMA pathways with specific decision frameworks to help you choose the right one based on risk and predicate availability.

FDA Regulatory Specialist

Name: FDA Regulatory Specialist
Author: zhangzhang-111-i

byzhangzhang-111-i

0•

보안 및 테스팅

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

This skill transforms Claude into a specialized FDA regulatory consultant for medical device manufacturers, helping navigate the complex landscape of federal requirements. It offers comprehensive support for identifying submission pathways like 510(k), PMA, and De Novo, while ensuring alignment with Quality System Regulation (21 CFR 820). Beyond submissions, it provides technical frameworks for HIPAA safeguards and modern cybersecurity standards, including Software Bill of Materials (SBOM) and threat modeling. This is an essential tool for R&D teams, quality managers, and developers building Software as a Medical Device (SaMD) who need to integrate regulatory compliance into their development lifecycle.

주요 기능

01HIPAA technical safeguard assessments for PHI-handling devices

02Step-by-step 510(k) submission preparation and RTA prevention

03Detailed 21 CFR 820 QSR compliance checklists and CAPA workflows

04Submission pathway decision frameworks for 510(k), PMA, and De Novo

05Cybersecurity threat modeling and SBOM documentation templates

060 GitHub stars

사용 사례

01Implementing Design Controls and quality systems for medical device manufacturing

02Determining the correct FDA submission pathway based on predicate device analysis

03Conducting cybersecurity risk assessments and threat modeling for connected devices

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add zhangzhang-111-i/claude-skills111 fda-consultant-specialist

For use in Claude.ai and ChatGPT

주요 기능

01HIPAA technical safeguard assessments for PHI-handling devices

02Step-by-step 510(k) submission preparation and RTA prevention

03Detailed 21 CFR 820 QSR compliance checklists and CAPA workflows

04Submission pathway decision frameworks for 510(k), PMA, and De Novo

05Cybersecurity threat modeling and SBOM documentation templates

060 GitHub stars

사용 사례

01Implementing Design Controls and quality systems for medical device manufacturing

02Determining the correct FDA submission pathway based on predicate device analysis

03Conducting cybersecurity risk assessments and threat modeling for connected devices