Medical Devices: Controlled from design to production
TECHMED WORKSHOP SERIES 4/6
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.
WHEN Thursday 14 December 2017, 14:00-18:00
WHERE Carre 3.022, Experimental Centre for Technical Medicine (ECTM), University of Twente, Enschede
14.00 - 14.15
Registration & Coffee
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
16.45 - 17.15
Production and service of medical devices
17.15 - 17.45
17.45 - 18.00
Questions & Closing remarks
Register before 8 December 2017, 12:00. We will welcome a maximum number of 50 participants, participation is free of charge.
This workshop is part of the TechMed Workshop Series ‘Remove the Barriers to Market Readiness’. This one-year-course of workshops covers the most important, but also most challenging, topics required for the development and production of a safe, reliable and useful medical device. The workshops are organized for (future) entrepreneurs in the medical device industry, take place every 2 months on an afternoon and focus on one specific topic every session. It is possible to attend the complete course, but also separate workshops.
The TechMed Workhsop Series is part of the TechMed Proeftuin. By sharing their knowledge and expertise in the workshops series the TechMed Proeftuin partners aim to bring medical innovations 1 TRL level further and closer to a successful market introduction. The TechMed Proeftuin receives funding from the European Regional Development Fund (ERDF) of the European Union; the Workshop Series can therefore be offered free of charge.
This workshop is powered by Proeftuin partner(s):