As part of its commitment to innovation, the Institut Laënnec organized two days of training on November 6 and 27, 2024, on the Timone Campus.
These sessions, specially designed to support healthcare professionals, researchers, teacher-researchers and PhD students, identified the issues involved in European medical device regulations and analyzed the requirements of ISO 13485.
These two days of training were led by GMED, notified body and European leader in certification in the healthcare and medical devices (MD) sector.
The first day on November 6 was devoted to exploring the requirements of the European regulation on medical devices, with an in-depth analysis of its structure and main provisions. Participants were able to cover a range of topics, including the scope of applications for medical devices, the roles and responsibilities of the various players involved, the classification of different types of medical device, safety and performance requirements, modes of proof, and the European medical device database .....
The second part of the Training session, on November 27, was dedicated to adapting the quality management system to ISO 13485, and provided an opportunity to analyze the requirements of the latter and identify the links between regulations and this standard.
