fda-consultant-specialist
CommunityFDA regulatory strategy for medical devices.
Authorovachiever
Version1.0.0
Installs0
System Documentation
What problem does it solve?
Senior FDA consultant guidance on pathways, QSR, HIPAA, cybersecurity, and regulatory submissions for medical devices.
Core Features & Use Cases
- Pathway analysis (510(k), PMA, De Novo)
- QSR compliance and CAPA strategy
- HIPAA risk and cybersecurity guidance
- Submissions planning and regulatory strategy
Quick Start
Develop a regulatory plan and select an optimal submission pathway for a device.
Dependency Matrix
Required Modules
None requiredComponents
references
💻 Claude Code Installation
Recommended: Let Claude install automatically. Simply copy and paste the text below to Claude Code.
Please help me install this Skill: Name: fda-consultant-specialist Download link: https://github.com/ovachiever/droid-tings/archive/main.zip#fda-consultant-specialist Please download this .zip file, extract it, and install it in the .claude/skills/ directory.