Navigating the Transition: Moving from FDA QMSR to ISO 13485 for Medical Device Quality Management
This workshop provides a structured learning process enabling participants to fully understand the nuances of moving from FDA QMSR to ISO 13485 for Medical Device Quality Management and create assessment & implementation plans within their organizations.
Workshop Outline:
1. Introduction to ISO 13485:2016
2. Rationale behind FDA’s decision and implications for medical device manufacturers
3. Detailed examination of various clauses of ISO 13485 and comparison with corresponding requirements in FDA QMSR
4. Strategies for transition planning – guidance on how to do gap assessment and developing an implementation plan
5. Guidance on readiness for FDA inspections and audits post-transition.
6. Best practices and lessons learnt from real-world examples (if any)
7. Training and competency development – recommendation of training programs and resources available.
8. Interactive exercises and Q&A