Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs 2019

Topics

• The purpose of the Medical Device Directives
• Regulatory status in relation to Medical Devices in the EU
• Directive Changes; Additional Requirements
• Meeting the New Requirements for Conformity Assessment by Product Type
• 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
• The impact the Directive will have on marketing and developing new Medical Device products
• Guidance Documents available to assist in the implementation of these directives

Who should Attend

• 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
• All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (25 expanded countries)
• CRO personnel