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 imminent implementation of the Medical Device Regulation, the European Competent Authorities are tightening up the requirements with regards to clinical evaluation both based on existing data as well as the requirements for prospective clinical investigations.
In addition, the MEDDEV documents 2.7.1 and 2.7.2 respectively on clinical evaluation and notifications reviews of clinical investigations by competent authorities also bring additional perspectives and requirements.
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 seminar will provide you an in depth review of how to interpret the many changes in the clinical evaluation requirements and how to discuss aspects of clinical evaluation with the notified bodies.
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
"Danielle Girourd was excellent and extremely knowlegdeable. She also adapted the course a little along the way dependent on request from participants"
Participants, Fall 2016