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2018 - Updated CE Marking Process & ISO 13485:2016 Expectations



VenueFremont, USA - United States USA - United States

KeywordsTraining Specialists; CAPA Specialists; Compliance Managers


Topics/Call fo Papers

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
Areas Covered in the Session:
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
Who Will Benefit:
Quality Assurance
Regulatory Affairs
Clinical Research and Medical Operations
Product Development
Manufacturing / Distribution
Medical Device R&D
Clinical Trial Supply
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.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

Last modified: 2018-08-10 14:29:33