QAdvis is now officially part of Aurevia. This change of name follows our company’s integration into Aurevia. The Aurevia brand was born in January, when Labquality, Artimed, Clinical Consulting, Kasve, and Prisma CRO merged under the same name. With QAdvis now proudly joining the team, we are further strengthening our expertise and services and together offering greater value to our joint customers. Scandinavian CRO is also joining Aurevia.
Welcome Noomi
We are very pleased to announce the joining of our new colleague Noomi Altgärde and extend a warm welcome to the QA&RA consultant team at QAdvis! Noomi has a PhD in Bioscience and a long background from working with medical devices in the development phase, with a focus on quality assurance and regulatory affairs. Her […]
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 […]