Course Description
This is a two-day workshop focusing on understanding the requirements of the Clinical Trial 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 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 Requirements
Medical Device Type & Process Path
Medical Device Technical File
Clinical Investigations
Clinical Evaluations
Notified Bodies
Gain a detailed understanding of all Guidance Documents available to assist in implementation of these directives
