In exciting news, our team will be attending the highly anticipated RAPS Convergence event in Long Beach from September 17th to 19th, 2024. The Regulatory Affairs Professionals Society (RAPS) Euro Convergence is an annual gathering of regulatory professionals from around the world who come together to discuss the latest trends and developments in the field [...]
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 [...]
