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.
QAdvis continue the collaboration with Labquality and will formally merge with them in the beginning of next year. In January 2025 we will together join the e-Hälsa MVTe 2025 in Stockholm. If you would like to know more about our joint services and how we can contribute to your business, contact Annelie Hagström or info@qadvis.com.
People often talk about the Post Market Surveillance (PMS) requirements in the Medical Device Regulation (MDR 2017/745), as a new requirement. But PMS was required long before MDR 2017/745 entered into force. So, what has actually changed? Post-market surveillance (PMS) is crucial in the medical device industry for several key reasons. Firstly, it is a […]
EU Regulation 2024/1860 includes an amendment to the MDR & IVDR regarding a gradual rollout of Eudamed modules and a subsequent change in compliance timelines for manufacturers. Regulation (EU) 2024/1860, adopted on 13 June 2024, introduces significant updates to the European regulations governing the rollout of the Eudamed database, as well as the obligations related […]
Welcome Melanie and Daniel!
We are pleased to introduce two new team members who will be strengthening our efforts in the Sales Department and Quality & Regulatory Services. Melanie brings a background in Mechanical Engineering with a focus on medical devices. As a Junior Consultant, she will be a valuable addition to our team of quality and regulatory consultants. […]
In most 510(k)s the FDA does not require clinical data, and class 1 devices are generally exempt from premarket submission requirements. Therefore, some companies conclude that they can save considerable time and money by not performing expensive studies…But is that really true? The U.S. Food and Drug Administration (FDA) has established three regulatory classes based […]