The topic of validation studies of technology-based medical devices with users was hilighted in a meeting with the members of MDevNet.
MDevNet is an initiative led by Fraunhofer Portugal AICOS that gathers many R&D institutions, industry, academia, public entities and end-user representatives. What brings the partners in the network together is their active involvement in the process of valuing technology transfer of technology-based medical devices.
The meeting was organized around three themes:
- clarification of legal issues associated with medical devices;
- obstacles and promotion of mechanisms for interaction between national entities involved in the process of co-development and validation of medical devices and
- effectiveness of technology transfer processes.
One of the topics was related to validation studies of medical devices with users and all the certification process.
In general, the conclusion of the meeting was that more information about regulations, processes and formalities is needed.