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.
- Teacher: Bronchart Nicolas
- Teacher: Demoustier Sophie
- Teacher: Geens Pierre
- Teacher: Ronsse Renaud