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.
IVDR Application Process – What do you need to know?
QAdvis have invited Charlotte Hess from BSI to give us some “need-to-know” when you plan for your IVDR-Application. Charlotte has solid knowledge of the IVD industry and understands the complexity of the IVDR applications. Whether you’re starting the certification process, looking to transfer or just need to discuss options for your business, she can guide […]
Local representative and what you need to know
Several countries require an in-country representative. This company is often chosen by the marketing department to market and distribute the medical devices in the country. But is this really the best strategy when it also includes being the regulatory contact with the authorities? The marketing department is without doubt the best department to choose sales […]
Finally, summer vacation!
During the late spring, the time for summer and for vacation can feel far away. But one thing is certain, it will always arrive and finally, now is the time to wrap up the first 6 months with a few words. The medical device industry has been home to some of the most revolutionary innovations […]
Gardening – Just like a medical device registration, it needs to be maintained!
Everyone who has a garden knows that the work in the garden is never done. Even if you have done your landscape planning according to the least burdensome approach, planted all the right plants and designed in perfect pathways, there will still come a day when your maintenance work starts. The situation is the same […]
Regulatory requirements are a design input.
What is the purpose of developing a medical device? If you ask your employees, the probable answer is that it is to help patients and fulfill user needs. Which is fair enough, but in order to do that we also need to understand that regulatory and government authorities also are included in the “user needs”. […]