Topics
- 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
- Guidance Documents available to assist in the implementation of these directives
- An overview of key areas of the Directive:Essential Requirements, Scope of application and definition, Medical Device Technical File, Medical Device Type & Process Path, Clinical Evaluations, Clinical Investigations and Notified Bodies
Who should Attend
Medical Device professionals including Project Managers, Clinical research and medical operations, Manufacturing personnel, Product Development personnel, Quality Assurance such as GMP, GCP Auditors, Researchers managing Medical Device R&D and Development, Clinical trial supply personnel, Regulatory affairs and CRO personnel.
