Entries by Johnnie Dahlberg

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 […]