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 is now Aurevia – expanding our capabilities together We are happy to announce that 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 […]
According to MDR 2017/745 “Devices shall be designed and manufactured in such a way as to ensure that their characteristics and performance during their intended use are not adversely affected during transport and storage…” This implies the need for transport validation, meaning that you must demonstrate that the device quality is not compromised during shipping […]
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 […]