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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