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.
Come and Meet Us at the Regulatory Summit on March 30th
We are present at Swedish Medtech’s Regulatory Summit on March 30th. Meet us here if you want to know more about what we do, or if you just want to have a quality and regulatory chat. And take the chance to listen to two of our most experienced consultants, Cecilia Emanuelsson and Cilla Lundevall.
Welcome Linda Lindberg!
We are happy to announce that QAdvis has a new consultant in our team, a warm welcome to Linda Lindberg! Linda has over 15 years of experience in product development and bringing new products to the market within the medical device, in-vitro diagnostic, biotech and pharmaceutical industries, both from start-ups and large international companies. She […]
QAdvis Collaboration with Swedish Medtech Continues in 2023
QAdvis will remain as a Swedish Medtech networking partner in 2023 and together we are offering up-to-date courses and seminars addressing current topics within the medical device quality and regulatory landscape. You can meet us at Swedish Medtech’s Regulatory Summit on March 30th if you want to know more, or if you just want to […]
Voting Complete – extension of MDR transition times and removal of sell-off period for devices from MDR and IVDR
The EU Parliament has adopted the MDR amendment proposal, February 16th, and removed the sell-off date for both medical devices and in-vitro medical devices. The amendment will come in force upon publication in the official journal, which is expected in the coming weeks. The European Parliament has on February 16th adopted the Commission proposal for […]
The 7th EAAR Annual Conference on the New Medical Device Regulations
Welcome 2-3 February in Brussels, Belgium to listen to Robert Ginsberg, Nils-Åke Lindberg and many other experienced speakers in the panel. Read more about the speakers here. RMD2023 homepage Registration here