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October 02, 2017

Qserve continues to grow!

To further strengthen our growing team of experts and to increase presence in the US and in Europe, we are happy to introduce a few colleagues who joined our team in the past few months.

August 30, 2017

Do you have sufficient clinical evidence for future EU-MDR compliance?

This blog looks at the impact of the new regulation on clinical studies you already performed, and clinical data you collected under the MDD, and challenges everyone’s decision to not perform additional clinical trials or PMCF studies.

August 24, 2017

Interview with Inette Nieveen on the Medical Device Regulatory changes in Europe

To help you understand the impact of the EU MDR, we have asked one of our experts to share her first experiences from a Regulatory consultant’s perspective, and therefore, we have set up an interview with Inette Nieveen. She has been involved in complex MDR implementation projects and is able to identify critical bottlenecks in the process. 


August 21, 2017

Consultation process under the new MDR - Is there anything new under the sun?

An increasing number of medical devices requires a consultation process under the new EU-MDR. Only then, an EU technical documentation assessment certificate can be issued for the device. 
August 16, 2017

An EU-MDR question from a customer, Keith Morel shares his extended answer.

As an EU-MDR expert, we are always willing to answer questions and share knowledge about the EU-MDR. This time, Keith Morel, VP Regulatory Affairs, gives an answer to a question about the use of Harmonized Standards in Clinical Evaluations, which might be interesting for all medical device manufacturers.


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