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
The Medical Device Regulations are now in place and will be enforced soon. In addition, the MEDDEV documents 2.7.1 rev 4 and 2.7.2 respectively on clinical evaluation and notifications reviews of clinical investigations by competent authorities also bring additional perspectives and requirements. In line with all these new requirements, ISO 14155 is being updated as well.
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
"Danielle explains in the way everybody understands. There is an interaction if needed"
"Excellent course leader, excellent structure, excellent that course leader had so many cases to relate to"
"Really competent teacher who clearly burned for the subject. She was good at giving examples and reviewing the legal"
Participants, Spring 2017