QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
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 […]
Welcome to QAdvis!
We are very pleased to welcome a new consultant, Nils Lidström to our QAdvis team! Nils has a master’s degree in system engineering and over 25 years of working with software development, the last 6 years with medical device software development using agile methodologies. Key areas of expertise are regulatory requirements and how to adapt […]
We wish all our customers and partners a Merry Christmas and a Happy New Year!
Every day a child is diagnosed with cancer. But there is hope. More children than ever survive their cancer today. We are proud to refrain from Christmas gifts and contribute to better health by supporting Swedish Childhood Cancer Foundation during Christmas 2021! Read our Diploma (Swedish). Link to the Swedish Childhood Cancer Foundation (Swedish).