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Updated CE Marking Process & ISO 13485:2016 Expectations

Event Details

Updated CE Marking Process & ISO 13485:2016 Expectations

Time: October 9, 2018 from 10am to 11:30am
Location: Online
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: https://www.compliance4all.co…
Phone: Event Manager
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Aug 7, 2018

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Event Description

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: support@compliance4All.com

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