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.
Human Factors Engineering (HFE) or Usability Engineering (UE) isn’t just about functionality and regulatory compliance, it’s about ensuring that devices are safe and easy to use for the end users by understanding human capabilities and limitations. The evolution of usability guidelines and standards for medical devices highlights an increasing recognition of the crucial role human […]
International Congress on Quality in Laboratory Medicine and Health Tech Labquality Days is one of Northern Europe’s largest annual international congresses focusing on quality in laboratory medicine and health technology. The inspiring atmosphere of the annual scientific congress gathers medical laboratory and health technology professionals together to exchange ideas and meet colleagues. Theese days brings […]
The EU Commission is urged to propose solutions by no later than the end of Q1, 2025. The revisions will seek to address the many challenges and bottlenecks associated with placing and maintaining medical devices within the EU market, particularly from the perspective of manufacturers and notified bodies (NB) in ensuring timely access to safe […]
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 […]