MDR for Dummies
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MDR for Dummies

MDR for Dummies

Date
08-06-2023
Time
13:00 - 18:00
Location
Aristo Meeting Center, Utrecht CS

General information

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!

Speaker

 

MDR for Dummies

Kelly van der Geest

Teammanager Medtech Innovation Support Office (MISO), ErasmusMC

Program

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
17:00 Q&A
17:30 Closing & informal drinks

Practical information

Aristo Meeting Center
Hoog Catharijne, Utrecht CS – Janssoenborch

Aristo Meeting Center, Utrecht CS
Aristo meeting center Utrecht CS, Action, Utrecht, Nederland
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Contact

Smart Industry

Nico Nijenhuis

n.nijenhuis@novelt.com

Circular Technology

Maurits Burgering

maurits.burgering@wur.nl

MedTech

Esther Rodijk

e.rodijk@novelt.com

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