This course will give clear and practical guidelines on how to navigate the development of a medical device in the regulatory landscape, and how to identify the correct development path. It focuses on Europe, but also addresses global standards.

Overview of the EU device legislative system and the principles and philosophy behind it will be discussed. Instructors will also explain the essential features of EU medical device regulation, such as essential requirements, risk classification, the relationship between risk classification and conformity assessment procedures and the role of notified bodies.

For medical devices that need to be tested clinically, the process of planning, conducting and reporting a clinical investigation with medical devices will be described in detail.

Furthermore, the process of drafting a design dossier will be highlighted, both for medical devices and for combination products.

CONTINUING EDUCATION
The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 18 credits.
DIA is an authorised training organiation accredited under the number 11 99 53383 75 to the Préfet of Ile-de-France.

What participants from previous courses say:
"I appreciated a lot the exercises and the examples we faced in the 3-days course"
"I enjoyed "exercise time" because attendees could discuss with each other. We got acquainted through this training course, thank you very much"
"I enjoyed this 3-day-course very much. It was a high quality course. Thank you very much to all of you, for your work, your expertise and also your advices"
"What I really liked is that, as the program of three days was anyway intense, there have been different break times to talk with the trainees and the colleagues and also to metabolise the concepts"