Understanding and Overcoming Challenges Encountered in Implementing the New ISO 13485:2016 Standard for Medical Device Quality Systems 2017

Topics

• 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

Who should Attend

• Design Engineers
• Quality Assurance
• Quality Control
• Research & Development
• Upper Management
• Supplier Management