Understanding and Overcoming Challenges Encountered in Implementing the New ISO 13485:2016 Standard for Medical Device Quality Systems 2017 is a webinar that covers topics such as:
- A quick comparison of how the new standard is harmonized with 21 CRF 820 and GHTF documents will be made
- Current vs Future of the ISO 13485 world: Risk based gap assessment
- Extension of the quality system requirements to the life cycle of the medical device
- Alignment of the standard to cater to the (Medical Device Single Audit Program MDSAP)
- Alignment with ISO 9001 and discussion of timeline for full implementation of ISO 13485: 2016
- Incorporation of changes to key areas such as customer feedback, Supplier management and CAPA
Understanding and Overcoming Challenges Encountered in Implementing the New ISO 13485:2016 Standard for Medical Device Quality Systems 2017 is intended for:
- Design Engineers
- Quality Assurance
- Quality Control
- Research & Development
- Upper Management
- Supplier Management