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.
New guidance for medical devices
by Health Canada
Health Canada has issued guidance on summary reports to implement a lifecycle approach to the regulation of medical devices in Canada. Health Canada has issued a guidance on Summary reports and issue-related analyses for medical devices to help medical device manufacturers comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulation. […]
by Health Canada
Strengthening the QA&RA team!
We warmly welcome our new colleague Lisa Lundberg Dellenvall in joining the QA&RA consultant team. Lisa has a Master’s degree in Chemistry and brings a wealth of experience from the international medical device industry. In particular, she is very well versed to bring clarity and stability in potentially complex design control processes. Further, her expertise […]
Midsummer weekend and Sweden’s summer holiday
Hello, this year’s Midsummer weekend, and the start for Sweden’s summer holiday season is just a few days away. For many of us, both working and everyday life became completely different, starting from March 2020. QAdvis has since then conducted its operations almost entirely on a remote basis. Different solutions made it possible to follow […]
Date of Application for the Medical Device Regulation
Today, May 26, 2021, is the Date of Application for the Medical Device Regulation (MDR 2017/745), one year later than initially planned. Over the past years, focus has been on the new regulatory requirements for all economic operators, and the pieces are finally starting to come together. For manufacturers, developing the technical documentation and implementing […]
Very welcome Frederik Roos!
We are very happy that Frederik has joined our team. Fredrik will hands-on support our clients to safely and effectively navigate through the product development aspects in a regulated environment. He has 12 years of experience from the medical device industry with many leadership roles within international product development. Frederik holds a M.Sc. in Chemistry […]