Go to content
iStock_000017318374XXXLargeFolder forside - Kopi

Medical devices

We have the people and the plans needed to assist you to make the right decisions for a successful entry of medical devices into the market.

Medical devices encompass a wide range of products. Today, there are more than 500,000 medical devices on the European market. Some are closely regulated and need extensive clinical documentation, whereas others have a classification that makes the path to CE marking and market access shorter.

For medical device clients we have established a dedicated team with experience and competence with the regulatory requirement from the different phases in the product development; from evaluation of the CE classification, creating documentation and clinical evaluation report to interaction with Notified Body. We have experience in planning, conducting and reporting of studies for medical devices as well as expertise to undertake health economic evaluations.

More about medical device

Download Medical Device flyer  


Related contacts:

1737 cropped hp Lars
Lars Guntveit
Global Director Medical Device 
Tel:+47 92 44 92 00
280x180- Jan
Jan Hellqvist
Managing Director
Tel: +46 70 913 51 25
marianne1- small HP
Marianne Holst
Managing Director
Tel:+45 22 15 85 56
Uwe Anzenberger
General Manager
Tel:+49 176 8227 0156
      +49  30 2461 2025