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
Post-Market Surveillance
Post-Market Surveillance
Post-Market Surveillance
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