Can it help with HIPAA compliance for software?

Yes, it includes tools for PHI data flow analysis, technical safeguard implementation, and business associate requirement management to ensure healthcare data protection.

Does it cover Software as a Medical Device (SaMD)?

Absolutely. It includes specific strategies for SaMD risk categorization, lifecycle documentation, and cybersecurity monitoring per current FDA guidance.

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

It provides a detailed framework for predicate device analysis, substantial equivalence strategy, and performance testing documentation required for a successful submission.

Can I use this for cybersecurity risk management?

Yes, it offers guidance on Premarket cybersecurity requirements, Software Bill of Materials (SBOM) documentation, and post-market threat intelligence monitoring.

How does it assist with FDA inspections?

The skill provides inspection readiness protocols, including quality system assessments, personnel training modules, and mock inspection simulations to prepare for audits.

FDA Regulatory Consultant Specialist

Name: FDA Regulatory Consultant Specialist
Author: BbgnsurfTech

byBbgnsurfTech

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보안 및 테스팅

Navigates FDA regulatory pathways and ensures QSR and HIPAA compliance for medical device development.

소개

The FDA Consultant Specialist skill transforms Claude into a senior regulatory expert capable of guiding medical device companies through complex FDA submission processes, Quality System Regulation (QSR) 21 CFR 820 requirements, and HIPAA data protection standards. It provides specialized frameworks for choosing between 510(k), PMA, and De Novo pathways, implements cybersecurity controls for connected devices, and offers strategies for inspection readiness and warning letter responses. This skill is particularly useful for regulatory affairs teams and developers building Software as a Medical Device (SaMD) who need to align their technical implementation with stringent federal healthcare requirements.

주요 기능

QSR (21 CFR 820) Compliance Frameworks and Gap Analysis
Medical Device Cybersecurity Guidance and SBOM Documentation
HIPAA Risk Assessment and Technical Safeguard Implementation
3 GitHub stars
FDA Submission Pathway Analysis (510(k), PMA, De Novo)
FDA Inspection Readiness and Mock Audit Support

사용 사례

Conducting HIPAA security evaluations and risk assessments for healthcare software systems.
Determining the correct regulatory pathway and predicate device for a new medical product.
Drafting documentation for Quality System Regulation compliance and design controls.

소개

주요 기능

QSR (21 CFR 820) Compliance Frameworks and Gap Analysis
Medical Device Cybersecurity Guidance and SBOM Documentation
HIPAA Risk Assessment and Technical Safeguard Implementation
3 GitHub stars
FDA Submission Pathway Analysis (510(k), PMA, De Novo)
FDA Inspection Readiness and Mock Audit Support

사용 사례

Conducting HIPAA security evaluations and risk assessments for healthcare software systems.
Determining the correct regulatory pathway and predicate device for a new medical product.
Drafting documentation for Quality System Regulation compliance and design controls.