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.
Tough times require sharp strategies – and the right expertise The industry’s financing climate has slowed down considerably. Investments in the development of pharmaceuticals and medtech are more cautious, and Ulrika Hammarström, Head of CRO at Aurevia, emphasizes that the requirements for a clear market and regulatory strategy have never been higher. For pharmaceutical, biotech […]
Navigating the regulatory landscape of the medical device sector is a complex task, requiring both strategic foresight and a deep understanding of evolving global requirements. Companies must not only ensure compliance with current regulations but also anticipate changes that could impact product development, market access, and post-market obligations. Within this context, two distinct but closely […]
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 […]