News from QAdvis

QAdvis congratulate Combinostics Oy on their MDR certificate

QAdvis want to congratulate their customer, Combinostics Oy, for achieving their MDR certificate with help from our highly skilled consultants. The transfer to MDR and/or IVDR is crucial for medical device manufacturers, to maintain market access in Europe. We are proud that we can be part of that journey for several customers, guiding as well as providing hands-on work during both the implementation […]

We are strengthen our office in Lund with a new site manager

The management team at QAdvis is delighted to announce that Annelie Hagström has been appointed as a new site manager in Lund starting from June 2022. Annelie is one of our Senior Quality and Regulatory consultants and has a broad and extensive experience within the medical device area and business development. She will continue to […]

QAdvis participate in Regulatory Summit 31, March

Meet our new CEO Emma Axelsson and listen to three of our consultants Cecilia Emanuelsson, Nils Lidström and Per Sundström at the upcoming Regulatory Summit hosted by Swedish Medtech on March 31. For the 5th year in a row, Swedish Medtech is holding a regulatory conference and interest in the subject is growing every year. […]

New CEO at QAdvis AB!

The Board of Directors at QAdvis is delighted to announce that Emma Axelsson has accepted the role of CEO, effective from February 1st 2022. “It is truly a pleasure to hand over this executive role to Emma. She has over the years gained a huge competence in the Medical Device area and is truly a […]

Publication of Regulation (EU) 2022/112

–A Risk based roll-out plan for certain In Vitro Diagnostic medical devices and In-house devices On 28 January 2022 the Regulation (EU) 2022/112 (CELEX number 32022R0112), amending new and updated transitional provisions to the IVD Regulation (EU) 2017/746, was published in the EU’s Official Journal after being signed on 25 January 2022 by the Presidents […]