Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs 2015

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
• 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

Who should Attend

Medical Device professionals and those involved in the registration of Medical Devices across the EU.