Advanced Search Webinars EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations 2018

Topics

• 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

Who should Attend

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