EU Medical Device Regulation (MDR) Updated CE Marking Process and ISO 13485:2016 Expectations is an event dedicated to the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
EU Medical Device Regulation (MDR) Updated CE Marking Process and ISO 13485:2016 Expectations covers topics such as:
- EU Regulatory and Legislative Structure
- EU Directives -> 2 EU Regulations
- EU Definition of a Medical Device
- Why the change from Directives to Regulations?
- Key Agencies Involved
- Updated Role of the Notified Body
- Overview of CE Marking Process & Changes Resulting from the EU MDR
- Essential Requirements -> Safety & Performance Requirements
- Medical Device Classifications
- Conformity assessment
- Integration of Risk Assessment / Risk Management
- MDR Overview (by Article & Annex)
- Device Vigilance & Reporting System
- Medical Device Single Audit Program (MDSAP)
- ISO 13485:2016 Updates
- Tips on Working with Regulatory Authorities
- Global Impact of ISO 13485:2016 Certification and CE Marking
EU Medical Device Regulation (MDR) Updated CE Marking Process and ISO 13485:2016 Expectations intended for:
- Executive Management
- Regulatory Affairs
- Quality Assurance
- Product Development
- Clinical research and medical operations
- Medical Device R&D
- Manufacturing / Distribution
- CROs
- Clinical trial supply
