This Medical device training will be discussing 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.
Upon completion of this course attendees will have a thorough knowledge of the requirements for developing and marketing Medical Devices in 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 requirements and to provide attendees with the latest information regarding interpretation and enforcement of these regulations.
Who Will Benefit:
This workshop will be of great value to Medical Device professionals and those involved in the registration of Medical Devices across the EU. It is primarily designed to benefit the following disciplines:
- Clinical research and medical operations
- Project Managers
- Product Development personnel
- Manufacturing personnel
- Researchers managing Medical Device R&D and Development
- Quality Assurance such as GMP, GCP Auditors
- Regulatory affairs
- Clinical trial supply personnel
- CRO personnel
- All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (25 expanded countries)
Note: ComplianceOnline provides 20% Discount on any Second purchase of Webinar