Does it cover software-specific regulations?

Yes, it includes specialized guidance for Software as a Medical Device (SaMD) and current FDA cybersecurity requirements including SBOM management.

Can it assist with FDA inspections?

Yes, it offers inspection readiness protocols, quality system assessments, and strategies for managing FDA communication and warning letter responses.

Can this skill help with 510(k) submissions?

Yes, it provides a comprehensive framework for selecting the right pathway, preparing device descriptions, and managing the submission lifecycle.

How does it handle HIPAA compliance?

The skill provides structured frameworks for administrative, physical, and technical safeguards, as well as risk assessment tools for PHI data flows.

FDA Regulatory & HIPAA Consultant

Name: FDA Regulatory & HIPAA Consultant
Author: pur3v4d3r

bypur3v4d3r

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Seguridad y Pruebas

Navigates complex FDA regulatory pathways, QSR compliance, and HIPAA requirements for medical device and healthcare software development.

This skill acts as a senior regulatory specialist, providing expert guidance on FDA submission strategies, Quality System Regulation (21 CFR 820) compliance, and medical device cybersecurity. It streamlines the preparation of 510(k), PMA, and De Novo submissions while ensuring technical safeguards meet HIPAA and healthcare data protection standards. Ideal for MedTech engineers and regulatory affairs professionals, it helps manage everything from initial pathway analysis and CAPA system implementation to FDA inspection readiness and post-market cybersecurity monitoring.

Características Principales

01QSR 21 CFR 820 compliance framework and design control guidance

021 GitHub stars

03FDA pathway selection strategy for 510(k), PMA, and De Novo requests

04FDA inspection readiness and Warning Letter response management

05Software as a Medical Device (SaMD) and cybersecurity regulation support

06HIPAA risk assessment and technical safeguard implementation

Casos de Uso

01Developing a regulatory submission strategy for a new connected medical device

02Conducting a HIPAA security audit and technical gap analysis for healthcare software

03Implementing a QSR-compliant Quality Management System (QMS) for a startup

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add pur3v4d3r/pur3-pkb-codebase fda-consultant-specialist

For use in Claude.ai and ChatGPT

Download Skill