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January 18, 2022

Understanding the IVDR Transition - There's still a lot of work to do

The new In Vitro Diagnostics Regulation (IVDR) transitional arrangements have now been published to the great relief of all stakeholders.
January 17, 2022

Kristiane Schmidt joins Qserve

Qserve Group is pleased to announce that Kristiane Schmidt has joined our team to further expand her capabilities in supporting our IVD team and IVD’s manufacturers worldwide.

January 06, 2022

Clinical Trials Regulation (CTR) for medicinal products in application on 31 January 2022

Relevant news for the those medical device manufacturers who also have pharmaceutical products: by the end of this month, on 31 January 2022, the pharma Clinical Trials Regulation (CTR) EU 536/2014 comes into application.
December 17, 2021

Happy Holidays and Best Wishes for 2022 from Qserve Group

This time of year is always extremely busy. Somehow we all feel pressure to finish things before we can start a well-deserved Christmas break.
December 17, 2021

BREAKING NEWS - Amendment to the IVDR transitional arrangements adopted

I am delighted to tell you that the proposal to amend the transitional arrangements of the IVDR and defer the application of some of the in-house requirements has been adopted.
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