New course on regulation of medical devices and in vitro diagnostic products
New course on regulation of medical devices and in vitro diagnostic products
New course on regulation of medical devices and in vitro diagnostic products
Training highly in demand by the pharmaceutical and medical device industry
The Mondragon University Polytechnic School, in collaboration with the Basque Health Cluster, is launching the new Expert Diploma in Medical Device Regulation (MDR) and In Vitro Diagnostic Devices (IVDR).
The healthcare sector is undergoing continuous transformation, and understanding the regulations and processes required to market new products is essential. This program has been designed with the most up-to-date content on the market and a practical and innovative approach taught by expert professionals from leading institutions in the Basque Country.
Practical Information:
- Synchronous online format
- Start: January 2026
- End: July 2026
Theoretical classes and workshops will be complemented by group work, debates, discussions, exercises, and simulations. The program also includes talks by external collaborators on specific topics and a final project.
Objective
The program aims to educate professionals on the regulatory steps required to market products: quality systems, documentation, certifications, safety, functionality, marketing, and more. The course aims to provide an in-depth and practical understanding of European Regulations MDR 2017/745 and IVDR 2017/746, enabling participants to confidently address the new quality, safety, and clinical evaluation requirements demanded by the European Union.
The course is primarily aimed at healthcare regulatory officials and staff, medical device designers/planners, and research staff, among others.