ComplianceOnline, Online Event
2012-08-23
Why Should You Attend: 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 training will be discussing the recently implemented and currently planned changes to the Medical Device Directives across the EU. It includes specific insight from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Specific targeted areas for change is discussed as well as the likely implementation timetable. Learning Objectives: Upon completion of this course, attendees will have a thorough knowledge of the ever-changing landscape to the EU Medical Device Directives across the European Union. The Directives are complex and the requirements differ somewhat by Member State. The content of this course is designed to simplify the understanding of all current requirements and to provide attendees with the latest insight to what the Commission believe are areas for improvement and what structure and requirements are likely to change. Areas Covered in the Seminar: - 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.
- Understanding the impact the Directive will have on developing and marketing new Medical Device products.
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