Updated CE Marking Process & ISO 13485:2016 Expectations

Overview:
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
Email: [email protected]

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WHEN AND WHERE

09 October 2018
United States of America

ORGANIZER

Netzealous LLC DBA - Compliance4All

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Added 5 years ago by Compliance4All on Manufacturing