EU laws and regulations for medical devices must guarantee a high standard of safety and quality of medical devices that are manufactured in, or supplied to member states in the EU. MDR came into force since 26 May 2021 and is intended to ensure that the medical devices placed on the market are safe and effective. However, unclarity, long waiting times and few experienced consulting specialists are known barriers that you have to overcome when bringing your innovation to market. In this workshop you will get an introduction to MDR from the perspective of development, design and manufacturing and some practical tools to get started when you develop a device yourself or are involved in it.
Join the workshop to learn from our experts and discuss with your peers!
Kelly van der Geest
13:00 Walk in, coffee & tea
13:30 Welcome & introduction
13:45 What are medical devices and what is the regulatory landscape?
14:00 The MDR; what should I do with it as a developer/engineer/researcher?
15:00 Short break
15:15 CE certification, market introduction and post-market surveillance
17:30 Closing & informal drinks
Aristo Meeting Center
Hoog Catharijne, Utrecht CS – Janssoenborch
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