News from QAdvis

Internship at QAdvis

We are happy to welcome Sneha Bangalore to QAdvis. Sneha has been hired via Jobbsprånget as an intern and will be a part of our teams in both Stockholm and Lund. She has recently finished her master’s degree in applied biotechnology from Uppsala University. During her master she has among other things studied molecular biotechnology, […]

Career at QAdvis

To our offices in Lund and Stockholm we are now looking for new colleges that will work together with us and our clients as Quality & Regulatory consultant within the Medical Device and In Vitro Diagnostic medical device industry. Read more here

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 […]