Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs 2015 is a webinar that covers topics such as:
- The purpose of the Medical Device Directives
- The current regulatory situation in relation to Medical Devices in the EU
- Understanding the impact the Directive will have on developing and marketing new Medical Device products
- Meeting the New Requirements for Conformity Assessment by Product Type
- Scope of application and definition
- An overview of key areas of the Directive:
- Medical Device Type & Process Path
- Essential Device Requirements
- Clinical Investigation Requirements
- Medical Device Technical File
- Notified Bodies involvement
- Clinical Evaluations
- Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs 2015 is intended for Medical Device professionals and those involved in the registration of Medical Devices across the EU.
