In June 2017 the TechMed Living Lab at the University of Twente (UT) started a series of six workshops for (future) entrepreneurs in the medical device industry.
Unitron as one of the partners of the TechMed Living Lab, wants to share its knowledge and expertise of Medical Device Regulation (MDR) in the workshop : Technical Requirements.
This workshop will take place on Thursday 14-12-2017 at 2:00 am , Carre 3.022, ECTM, Universiteit Twente, Enschede.
In order to market medical products, many requirements must be met. Within the European Union, these requirements are imposed by Medical Device Regulation (MDR), formerly known as Medical Device Directive (MDD). For one thing, the development of medical devices is subject to strict conditions. Furthermore, the entire production process must be validated in full. And in addition, setting up a supply chain is a key element of the production system, in which continuity and quality are paramount. All logistical aspects with regard to the purchasing and verification of materials, as well as (worldwide) shipping of complete end products play an important role. Other business aspects are equally important. This is certainly true for medical products, where each country has its own rules and regulations to market products, both in Europe and beyond.
14:15-14:45 Introduction to medical market
14:45-15:15 Medical Device Regulations and standards for (CE)
15:15-15:45 Development of medical devices
15:45-16:15 Design Transfer activities
16:15-16:45 Short break
16:45-17:15 Production and service of medical devices
17:15-17:45 Business aspects.