Design studio Panton creates safe and user-friendly products for healthcare through design. Holland Innovative supports companies in the development of medical devices through project management, process development and support in complying with applicable regulations. Fris & Fruitig develops smart and safe software for the medical sector in which CE certification plays a role.
On a regular basis, Panton and Holland Innovative are asked for advice about the application of the regulation for medical devices, since they have a lot of experience in this area. They often receive the same, or similar questions. Together they believe that the regulation should not be a barrier to the development of medical devices. The regulation is meant to make devices and innovations safe, not impossible. By combining their expertise, they designed this website to aid manufacturers and designers in understanding the basics of the Medical Devices Regulation, the MDR.
Fris & Fruitig's mission is to enable new, better care by developing smart medical technology. The focus is on data and connectivity, standalone or around medical devices. As software plays an increasingly important role in medical technology, Fris&Fruitig endorses the importance of having good legislation in place during its development. The MDR offers tools for developing software in a responsible manner but is not presented in an easily accessible manner. With the latest techniques, Fris & Fruitig developed this CE Tool, which provides better insight into the consequences of certain choices during the development of medical technology.
This tool helps users in the process
Solutions to complex issues require an interdisciplinary approach. This tool is an example of such a fruitful collaboration. By asking questions about the new device or app, the tool guides the user through the most important steps in the regulation, required to obtain a CE certificate.
7511 GD Deventer
+31 (0)570 64 02 77
7521 AN Enschede
+31 (0)408 51 46 10
High Tech Campus 29
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+31 (0)408 51 46 10
7523 XC Enschede
+31 (0)533 69 00 08