Getting Started
Quality Management System
- Establish Quality Management System
- Training
- Purchasing, Sales and Suppliers
- Computer System Validation
- Audits and Review
Planning
- Device Characteristics and Classification
- Design and Development Plans
Design and Development
- User Needs
- Risk Management
- Product Requirements
- Design
- Design Stage Checklists
Verification and Validation
- Usability and Human Factors Engineering
- Manufacturing
- Verification and Validation Planning
- Verification and Validation Reports
- Verification and Validation Stage Checklists
Regulatory Preparation
- Labeling, Instructions for Use, and Manuals
- Post-Market Surveillance
- Clinical Evaluation
- Performance Evaluation
- General Safety and Performance Requirements Checklist
- Deployment
Submission
- Product Release
- Declaration of Conformity
- UDI Creation and EUDAMED Registration
- Technical File
- Medical Device File
- FDA Registration
- FDA Submission
Post Market
- Product Changes
- CAPAs and Vigilance
- Surveillance Reports
- Complaints
UDI Creation and EUDAMED Registration
UDI Creation and EUDAMED Registration
UDI Creation and EUDAMED Registration
Content coming soon.
On this page
Assistant
Responses are generated using AI and may contain mistakes.