Webinar Duration: 90 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: 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.
Learning Objective:
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
Course Agenda:
– 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
– CRO’s
SPEAKER PROFILE:
Robert J. Russell For the past 9 years, He 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.
