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Led by Richard Young, trainer for MDTI's 'Managing the Transition to the new IVD Regulation' and 'Practical Guidance for Medical Device Audits and Inspections' courses, this c. 20 minute webinar covers:
- Impacts of the new revision
- New terminology
- General requirements
- Resource management
- Product realisation and design controls
- Q&A session
Over c.30 minutes, this webinar explores a major area of development from the last decade. Presented by Richard Young, it covers:
- The changing regulatory environment for medical devices in Europe
- FDA regulation
- Key considerations in development environments
- Key standards