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May 26, 2022

Wake up to the IVDR! Today, the 26th of May, is the 'Date of Application', the date the new IVDR goes live

Wake up to the IVDR! Today, the 26th of May is the “Date of Application”, the date the new IVDR goes live. Many describe this as a cultural shift as it does not just change the regulation but in many cases the way we do business. It will impact all IVDs on the EU market and the associated supply chain.
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May 24, 2022

Wouter Mattheussens joins Qserve

Wouter Mattheussens has joined Qserve Group where he is part of the Qserve CRO team and works as a Clinical Project Manager.
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May 17, 2022

Saskia Schoenmakers joins Qserve

Saskia Schoenmakers has joined Qserve Group as a consultant where she is part of the IVD team. With her experience in IVD product development, technical documentation and technical & application support, she will make a valuable contribution to our global customers.
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May 13, 2022

It’s a small world after all… but with big differences in regulation

Nearly every jurisdiction around the world has a formalized registration process that medical device manufacturers must follow to legally sell a product into markets. Let’s have a look at the mid-size European medical device manufacturer.
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May 09, 2022

MDCG 2022-5 and the concept of “liable to act on the body” - Much ado about nothing?

The guidance on the borderline between medical devices and medicinal products is now released in its final version. Its publication is very welcome as it replaces the old “borderline manual”, formally only applicable to MDD but practically, lacking alternatives, still used to unravel complex MDR classification issues.
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