Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Program (FDA GXP Compliance -)
Venue: Online Event
|Event Date/Time: Jun 29, 2012||End Date/Time: Jun 29, 2012|
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.
- 2010 Directive Changes; Additional Requirements.
- Understanding the impact the Directive will have on developing and marketing new Medical Device products.