In exciting news, our VP Quality and Regulatory affairs will be attending the highly anticipated RAPS Euro Convergence event in Amsterdam from May 10th to 12th, 2023. 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 [...]
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So far Robin has created 4 blog entries.
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 [...]
It has been challenging to meet deadlines and milestones for the clinical trials where patient availability has decreased and due to limited support the clinical trials have been reduced to the minimum where possible. Nevertheless, patient support and follow-up continues for safety and health reasons and a skeleton study crew is always available. In [...]