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November 28, 2017

What is the impact of the General Data Protection Regulation (GDPR) and the EU-MDR on medical devices that process personal data?

Since the increasing connectivity (Internet of Things) of medical devices over IT-Networks, like cloud solutions and the rapid integration and use of software applications (standalone or integrated), data protection is an essential requirement to preserve patient safety.
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November 13, 2017

Interview with Inette Nieveen on the effects of the Medical Device Regulation in Europe

In this interview, she will share with us the opportunities and challenges within the EU-MDR.
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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.

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September 12, 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.

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August 28, 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. 

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