Clinical Evaluation for Medical Devices in Europe and International Approach
Course targeted towards clinical project managers, clinical research associates and others working in the field of clinical investigations
With the new Medical Device Regulations in place, it brings a whole new challenge for many companies to update their approach to gather the necessary clinical data for CE-mark. As there is no grandfathering of existing products on the market, all medical devices CE or not CE-marked are concerned about the Medical Device Regulation’s requirements immediately.
With these new regulations, many companies who may not have thought about the need for clinical investigations, now face an additional challenge in conducting prospective clinical investigations. Along with MDR, ISO 14155 has undergone a significant update and it’s final draft is close to being published.
Furthermore, the relationship companies have with their notified bodies is definitely changing, as a result of the changing climate with regards to the need for more clinical evaluation data. .
This 2-day course will provide you an in depth review of how to interpret the many changes in the clinical evaluation/investigation requirements and how to discuss aspects of clinical evaluation and investigations with the notified bodies.
Practical examples will be given in how to prepare the clinical strategy for Europe but also integrate requirements of other geographic areas such as the US, China and ASEAN countries into a global strategy.
Who should attend?
This course is targeted towards clinical project managers, clinical research associates and others working in the field of clinical investigations for medical devices.
The course will be conducted in English, alternating between lectures and studies.
Danielle Giroud, CEO, WMDO (World Medical Device Organization) and CEO MD-CLINICALS
"I liked the thorough review of ISO 14155:2020 and MDR"
"Trainer was very knowledgable and very experienced"
"Expert insight into the discipline of clinical evaluation, incl. clinical trials, with a practical take on the tasks of writing CEP, CER and CIP"
"The presenter/teacher is very knowledgible and explains concepts clearly"
"Good combination with group lecture, case-work and possibility to ask individual questions"
Participants, Fall 2020