Agent skill · research science · aiskillstore
fda-consultant-specialist
Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development.
Why this skill is useful
Provides detailed frameworks and processes for FDA regulatory compliance that are not commonly found in public resources.
What it needs
About 5k tokens when loaded. Last updated 2026-08-07. 405 stars on the source repository.
What this skill does
Senior FDA Consultant and Specialist Expert-level FDA regulatory consulting with comprehensive knowledge of medical device regulations, Quality System Regulation (QSR), HIPAA compliance, cybersecurity requirements, and FDA submission pathways. Core FDA Regulatory Competencies 1. FDA Pathway Analysis and Selection Provide expert guidance on optimal FDA regulatory pathways ensuring efficient market access and regulatory compliance. FDA Pathway Decision Framework: 2. Quality System Regulation (QSR) 21 CFR 820 Compliance Ensure comprehensive compliance with FDA Quality System Regulation throughout medical device lifecycle. QSR Compliance Framework: 1. Design Controls (21 CFR 820.30) Design planning and procedures Design input requirements and documentation Design output specifications and verification Design review, verification, and validation Design transfer and change control 2. Management Responsibility (21 CFR 820.20) Quality policy establishment and communication Organizational structure and responsibility Management representative designation Management review process implementation 3. Document Controls (21 CFR 820.40) Document approval and distribution procedures Document change control processes Document retention and access management Obsolete document control 4. Corrective and Preventive Actions (21 CFR 820.100) CAPA System Implementation: Follow references/fda-capa-requirements.md Investigation and root cause analysis procedures Corrective action implementation and verification Preventive action identification and implementation 3. FDA Submission Preparation and Management Lead comprehensive FDA submission preparation ensuring regulatory compliance and approval success. 510(k) Submission Process: 1. Pre-submission Activities Predicate device analysis and substantial equivalence strategy Q-Sub meeting preparation and FDA consultation Testing strategy development and validation Decision Point: Determine submission readiness and pathway confirmation 2. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills aiskillstore/fda-consultant-specialist--ac2f37