Introduction
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 and is currently still undergoing significant updates. In addition, a new standard (ISO 18969) is being prepared and this works leads to interesting approach on the methodology for clinical evaluation which the instructor will share during the course.
 
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 medical writers, clinical project managers, clinical research associates and others working in the field of clinical investigations for medical devices.

Course language
The course will be conducted in English, alternating between lectures and studies.
  
Instructor
Danielle Giroud, CEO, WMDO (World Medical Device Organization) and CEO MD-CLINICALS
 

"Danielle Giroud was very present, engaged and used her slides as backup but did not just read them. She had many examples and was open for questions which she used as examples"

"I especially liked the the sections on legacy devices and MDR update of these"

"It was a very knowledgeable and experienced course instructor"

"Danielle is good at explaining things"

"I liked the first day, going through the CEP, which was of most relevance to me. I also appreciated the teacher being very experienced and knowledgeable"

Participants, Spring 2021