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.
For nearly 30 years, the U.S. Food and Drug Administration has played a pivotal role in shaping the global medical device industry through strict regulatory requirements, international cooperation, and adaptation to technological advancements. However, with significant changes on the horizon in the U.S., how will these developments affect medical device manufacturers in Europe? The United […]
The Health Technology Assessment Regulation (HTAR), officially known as Regulation (EU) 2021/2282, marks an advancement in the evaluation of health technologies within the European Union. Effective from January 12th, 2025, the HTAR aims to harmonize the assessment processes for health technologies, including medical devices (MDs) and in vitro diagnostic medical devices (IVDs), across EU member […]
QAdvis is delighted to announce that Anna-Karin Alm has joined QAdvis as the new CEO, effective from February 1st 2025. We are delighted to announce the appointment of Anna-Karin Alm as the new CEO of QAdvis AB, succeeding Robert Ginsberg, who has decided to step down from this position. Anna-Karin also assumes the QA/RA Business Area […]
We at QAdvis want to wish you a joyful holiday season and say thanks for what we have achieved together throughout the year. As a part of the Labquality family we look forward to continuing our journey with all clients, colleagues and partners in 2025. Contact us if you need more information or hands on assistance.
Compliance with ISO 13485 and EU MDR/IVDR require clear evidence of effective control over measuring and monitoring processes, equipment, and calibration—a requirement that is easy to underestimate or overlook. EN ISO 13485:2016/A11:2021 contains a section (7.6) dedicated to the control of monitoring and measuring equipment, which includes both a determination of the monitoring and measurements […]