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.
Update of the guidance for medical device software applications (apps)
MHRA (Medicines and Healthcare Products Regulatory Agency) has published an update of the guidance for medical device software applications (apps). The guidance provides information on when software applications are considered to be medical devices and how these shall be regulated. The guidance consists of an overall document and three appendices. • Medical Device stand-alone software, […]
Book of the Year Award
Fantastic news! Regulatory Affairs Professional Society (RAPS) has congratulated Robert Ginsberg and Mikael Dahlke for their efforts in co-writing Software as a Medical Device as a “publication that is well-written, accurate, relevant, and presents new information that fills a gap in regulatory knowledge on an emerging, cutting-edge, or state-of-the-art topic.” It was selected for the […]
Kista All Stars
QAdvis participated in the event Kista All Stars in June, to connect and celebrate together with other amazing companies that all had achievements and awards to be proud of. A great possibility for inspiration and to meet others and network with our neighbors in Kista Science City, as well as getting inspired by fantastic people […]
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 […]