Manufacturers of medical technology products, ranging from syringes to imaging scanners, are facing a significant increase in the requirements of Notified Bodies and Competent Authorities for market authorization. A new European regulation including new concepts for clinical validation came into force in 2017. For IVD, the changes are even more radical because about 50% of the products that were placed on the market for autocertification will require the passage through a Notified Body. These changes are causing a lot of pressure on the employees in charge of Clinical Affairs & Regulatory Affairs & Quality Assurance activities – i.e. CARAQA. In addition, the new European regulations will formally require a “Qualified Person” in the organizational chart of the company in the same way as the pharmaceutical industry. The CARAQA.be certificate for medical devices and IVD faces broad opportunities to evolve towards the company’s decision-making centers and to play a key role in maintaining the competitiveness and sustainability of the company.
Biomedical engineers contributes to the development of cutting-edge technologies being used for better diagnosis and treatment of various pathologies. Graduated biomedical engineers are usually very good in technical skills regarding a large palette of technologies (imaging, stimulation, modeling, robotics, etc.) and soft skills like project management. However, their curriculum does not prepare them to face the “non-technical” aspects that are ubiquitously surrounding the development of any biomedical technology: certification, clinical validation, reimbursement and health economy, IP management, etc. This certificate thus covers all aspects related to these so-called “clinical, regulatory, and quality affairs” that are prominent in the biomedical ecosystem. Several speakers – experts in these fields – cover these highly multidisciplinary topics, with an adequate balance between full and invited professors from UCLouvain, and industrial experts.