EU Medical Device Regulation (MDR) – Updated CE Marking Process and ISO 13485:2016 Expectations

Why Should You Attend:

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.

Areas Covered in the Webinar:

• EU Regulatory and Legislative Structure
• EU Definition of a Medical Device
• 3 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

Who Will Benefit:

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
• CROs

Robert J Russell
President, RJR Consulting, Inc

For the past 9 years, Robert J. Russell has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

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