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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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July 25, 2017

Funneling the bottlenecks! – The quest for clarity

So, what is everybody up to these days? Scheduling a family summer break or frantically working on the MDR project? Most important before you leave your laptop and find some quiet reading spot on a beach with a nice view, is to ensure you have funneled the bottlenecks you have so far identified into the clarification machines in Europe.
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July 25, 2017

100% Medical Device dedicated Qserve CRO

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July 11, 2017

Five reasons to start your MDSAP readiness now!

For a long time GHTF and its successor IMDRF have focused on providing guidance and harmonization. But recently they have moved to the next level of harmonization in practice. The first project is the so-called MDSAP program, the Medical Device Single Audit Program. 
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July 05, 2017

Qserve team is growing and expanding!

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

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