WEBINAR
How To Manage Design And Development Of Medical Devices According To ISO 13485:2016 / 21 CFR Part 820.30 ?
Mercredi 8 novembre de 15h00 à 16h00
1. Regulatory Context
- ISO 13485:2013 & 21 CFR Part 820
- Medical Device Product Development Lifecycle
2. The Iterative Design Control Process
- Process Model
- Activities & Deliverables
3. 1+5 Essential Building Blocks of Design Control
- The PADC - Cycle
- Document Management
- Requirements Management
- Risk Management
- Change & Non-Conformity Management
- Traceability
4. Software Solutions Designed To Facilitate Compliance With FDA 21 CFR Part 820.30 / ISO 13485:2016
- Process Analysis & Coaching
- Reqtify : Requirements Management for Office Based QMS Systems
- Dassault's Product Lifecycle Management System for Medical Devices : DHF Based Project Management > Demonstration