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.
The new regulations on medical devices are now published in the Official Journal of the European Union
The texts are available following this link. The Medical Devices Regulation is identified as Regulation (EU) 2017/745. The In Vitro Diagnostic Medical Devices Regulation is identified as Regulation (EU) 2017/746.
Positive vote in the European Parliament on 5th April regarding EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR)
The regulations will entry into force 20 days after publication in the EU Official Journal. Publication is expected to occur in May.
New member of our team – Emma Axelsson
Welcome Emma! Emma is located at our Stockholm office. Read more about Emma here.
Final draft texts of MDR and IVDR
The final draft text of MDR is available through this link. And the final draft text of IVDR is available through this link.
Presentation materials now available on our web page
Materials from breakfast seminars and webinars can be found at this link.