Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . 

Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

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Updated CE Marking Process & ISO 13485:2016 Expectations

Start Date : October 9, 2018
End Date : October 9, 2018
Time : 10:00 am to11:30 am

Phone : 800-447-9407
Email : support@compliance4All.com

Location :
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

Website

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

Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . 

Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

Tel: 800-447-9407
Mobile: 8004479407
Email: support@compliance4All.com
Website: http://www.compliance4all.com/


Event Categories: Health & Nutrition.




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