Advanced Search Webinars EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations 2018 is a webinar that covers topics such as:
- EU Definition of a Medical Device
- EU Regulatory and Legislative Structure
- Key Agencies Involved
- 3 EU Directives -> 2 EU Regulations
- Overview of CE Marking Process & Changes Resulting from the EU MDR
- Why the change from Directives to Regulations?
- Medical Device Classifications
- Updated Role of the Notified Body
- Integration of Risk Assessment / Risk Management
- Essential Requirements -> Safety & Performance Requirements
- Device Vigilance & Reporting System
- Conformity assessment
- ISO 13485:2016 Updates
- MDR Overview (by Article & Annex)
- Global Impact of ISO 13485:2016 Certification and CE Marking
- Medical Device Single Audit Program (MDSAP)
- Tips on Working with Regulatory Authorities
Advanced Search Webinars EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations 2018 is intended for medical device professionals from:
- Quality Assurance
- Executive Management
- Clinical Research and Medical Operations
- Regulatory Affairs
- Manufacturing / Distribution
- Product Development
- Clinical Trial Supply
- Medical Device R&D
- CRO`s