Live webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs By Compliance2go October 12, 2012

Why Should You Attend
This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The course covers all relevant topics in brief associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation.
Key Topics to be Discussed:
The current regulatory situation in relation to Medical Devices in the EU.
The purpose of the Medical Device Directives.
Meeting the New Requirements for Conformity Assessment by Product Type.
Understanding the impact the Directive will have on developing and marketing new Medical Device products.
An overview of key areas of the Directive:
Scope of application and definition
Essential Device Requirements
Medical Device Type & Process Path
Medical Device Technical File
Clinical Investigation Requirements
Clinical Evaluations
Notified Bodies involvement
Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.
Detailed Agenda of the Session
Definition: Medical Device or Personal Protective Equipment.
Overview of the Global Medical Device Industry
Standard
Active Implanted
In Vitro Diagnostic

Official Website: https://compliance2go.com/index.php?option=com_training&speakerkey=11&productKey=21