EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
Robert J. Russell Overview:
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.
Areas Covered in the Session:
- EU Regulatory and Legislative Structure
- EU Directives -> 2 EU Regulations
- Key Agencies Involved
- Why the change from Directives to Regulations?
- Overview of CE Marking Process & Changes Resulting from the EU MDR
- Updated Role of the Notified Body
- Medical Device Classifications
- Essential Requirements ->Safety & Performance Requirements
- Integration of Risk Assessment / Risk Management
- Conformity assessment
- Device Vigilance & Reporting System
- MDR Overview (by Article & Annex)
- ISO 13485:2016 Updates
- Medical Device Single Audit Program (MDSAP)
- Global Impact of ISO 13485:2016 Certification and CE Marking
- Tips on Working with Regulatory Authorities
Learning Objectives:
- Upon completion of this course, attendees will have enhanced knowledge of the ever-changing landscape of Medical Device Regulation in the EU
- The content of this course is designed to simplify the understanding of requirements and to provide attendees with the latest insight on how changes are being viewed and implemented by companies marketing products in the EU
Who will Benfit:
This workshop will be of great value to Medical Device professionals and those involved or interested in the registration of Medical Devices across the EU. It is primarily designed to benefit personnel within the following disciplines:
- Executive Management
- Quality Assurance
- Regulatory Affairs
- Clinical Research and Medical Operations
- Product Development
- Manufacturing / Distribution
- Medical Device R&D
- Clinical Trial Supply
- CRO's
Speaker Profile
Robert J. Russell is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.
His experience and knowledge span Healthcare Authority's requirements and regulatory processes across Life Science products.
For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries.
He holds a BS / MS in Chemistry."