Can it assist with software-specific medical device issues?

Absolutely. It covers HIPAA technical safeguards, FDA cybersecurity requirements including SBOM and threat modeling, and AI/ML SaMD frameworks.

Does it help with the transition to the new QMSR?

Yes, it includes specific frameworks and checklists for transitioning from the legacy 21 CFR 820 (QSR) to the ISO 13485-aligned QMSR framework effective in 2026.

What submission pathways does this skill support?

The skill provides guidance for 510(k) (Traditional, Special, Abbreviated), De Novo, and PMA (Premarket Approval) pathways based on device classification.

Does this skill include automated tools?

Yes, it features integrated Python scripts for tracking submission milestones, checking QSR compliance against project files, and performing HIPAA risk assessments.

FDA Regulatory & Compliance Consultant

Name: FDA Regulatory & Compliance Consultant
Author: borghei

byborghei

•

Security & Testing

Provides expert guidance on FDA medical device submission pathways, Quality System Regulation (QSR/QMSR) compliance, and healthcare cybersecurity standards.

This skill transforms Claude into a specialized FDA regulatory consultant, offering end-to-end support for medical device manufacturers and software developers. It assists in selecting the optimal regulatory pathway (510(k), PMA, or De Novo), implementing Quality Management Systems aligned with 21 CFR 820 and ISO 13485:2016, and ensuring compliance with HIPAA and FDA cybersecurity requirements. Whether you are navigating pre-submission strategies, preparing technical documentation for Software as a Medical Device (SaMD), or managing the transition to the new QMSR framework, this skill provides actionable frameworks and automated tracking tools to streamline the regulatory process.

Key Features

01Regulatory pathway decision frameworks for 510(k), PMA, and De Novo submissions

02Automated submission tracking and compliance checking via integrated Python scripts

03HIPAA risk assessment and technical safeguard implementation for medical devices

0450 GitHub stars

05Cybersecurity threat modeling and Software Bill of Materials (SBOM) guidance

06Comprehensive Quality System Regulation (QSR) and QMSR (ISO 13485) compliance mapping

Use Cases

01Determining the appropriate FDA submission pathway and identifying predicate devices

02Drafting documentation for Quality Management Systems (QMS) and Design Controls (820.30)

03Evaluating Software as a Medical Device (SaMD) for HIPAA and cybersecurity readiness

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add borghei/claude-skills fda-consultant-specialist

For use in Claude.ai and ChatGPT

Download Skill