In May 2015, René Roncken and Robin Lucchesi decided to found the company to be able to provide services to the medical device industry in the process for obtaining and maintaining CE-mark for medical devices or market access in the European Union. With broad knowledge and insight into the process of medical device development, the [...]
The Regulation (EU) 2017/745 on medical devices (MDR) was created with the aim of increasing patient safety by introducing rigorous testing procedures. Those procedures are intended to prevent unsafe or non-compliant devices from being placed on the market and emphasized the supervision of the devices when they are placed on the market. This also has [...]
MedQ Consultants B.V. will continue to provide EU Authorized Representative services under the Medical Device Regulation (EU) 2017/745 (MDR). When the MDR was released, it became clear that the regulation adds more stringent obligations to manufacturers and authorized representatives. The obligations of authorized representatives are described in MDR Article 11. An EU authorized representative [...]
