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.
Welcome to us Kecke Elmroth
With a solid background from Medical Affairs in MedTech industry and academic Life Science research, Kecke is skilled in clinical/scientific reading, writing, and interpretation. She is well-experienced in clinical evaluation, post-market clinical follow-up, clinical evidence gap identification, systematic literature search, and claims substantiation for regulatory purposes. Kecke is used to provide Medical Affairs input to […]
Is UDI for medical devices as complicated as it seems?
Purpose of implementing a device identification system is to improve patient safety by making the traceability of devices more efficient and simplify a FSCA (Field Safety Corrective Action) e.g. recall of devices. In parallel, the post-market safety-related activities for devices will also be more robust and allow a better monitoring by the competent authorities. UDI, […]
Welcome onboard Sneha Bangalore
After 4 months of internship at QAdvis we are now happy to welcome Sneha to the QAdvis Team as a consultant. Sneha has during her internship gained an overview insight of Quality and Regulatory consulting and will now continue to act as support within certain projects. Sneha contributes with her positive attitude, a quick understanding […]
Thanks to Swedish Medtech Regulatory Summit
Last week we were present at the Swedish Medtech Regulatory Summit. A big thank you to Swedish Medtech for a great event and thank you to all of you visiting our both on site and digital as well as listening to Cecilia Emanuelsson and Cilla Lundevall. If you would like to know more or if you have […]
… with BSI regarding MDR-Application Process
MDR Application Process – What do you need to know? QAdvis have invited Magnus Olla from BSI in Sweden to give us some “need-to-know” when you plan for your MDR-Application. Magnus will also talk a about the new regulation 2023/607 amending regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical […]