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fda-consultant-specialist

Identify FDA pathways and regulatory documents for medical device submissions.

Updated Mar 5, 2026
Search Tags:#compliance#fda#510k#hipaa#pma#qsr#denovo
One-click install
npx skills add https://github.com/theandyalvarez7-ruby/claude-skills --skill fda-consultant-specialist-theandyalvarez7-ruby
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: fda-consultant-specialist
Source: https://github.com/theandyalvarez7-ruby/claude-skills/tree/main/ra-qm-team/fda-consultant-specialist
Command: npx skills add https://github.com/theandyalvarez7-ruby/claude-skills --skill fda-consultant-specialist-theandyalvarez7-ruby

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) components.

What problem does it solve?

FDA regulatory consultant for medical device companies helps align strategy, documentation, and compliance across FDA pathways.

Core Features & Use Cases

  • Pathway selection guidance and regulatory decision matrices
  • Submissions readiness checks and document gap analysis
  • HIPAA risk assessment and QSR/compliance planning
  • CAPA alignment and regulatory project management support
  • Example: A startup uses this to map a device to 510(k) vs De Novo and generate required docs

Quick Start

Ask me to generate a submission readiness plan for a new medical device.

Frequently Asked Questions about fda-consultant-specialist

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I determine the right FDA pathway for a new medical device?▼

A 510(k) submission requires a predicate device and substantial equivalence documentation, while a De Novo applies to novel low-to-moderate risk devices without a predicate. This skill outlines the required documents and workflow guidance for both pathways to streamline your submission.

How do I prepare for a 510(k) submission versus a De Novo classification?▼

A 510(k) submission requires a predicate device and substantial equivalence documentation, while a De Novo applies to novel low-to-moderate risk devices without a predicate. This skill outlines the required documents and workflow guidance for both pathways to streamline your submission.

What documents are needed for PMA submission readiness checks?▼

PMA submission readiness checks require clinical data, QSR compliance records, and comprehensive risk analysis documents. This skill performs document gap analysis and outputs actionable readiness checklists to identify missing components before submission.

Can I generate a HIPAA risk assessment and QSR compliance plan for early-stage devices?▼

You can generate HIPAA risk assessments and QSR compliance plans for early-stage devices using this skill. It applies regulatory planning across early-stage to mature devices to ensure CAPA alignment and streamline compliance documentation.

What is the best way to handle cybersecurity planning for FDA medical device submissions?▼

Cybersecurity planning for FDA submissions involves integrating risk assessment and QSR compliance protocols into your device documentation. This skill provides reference materials and workflow guidance to align cybersecurity measures with regulatory project management support.

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