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.
In most 510(k)s the FDA does not require clinical data, and class 1 devices are generally exempt from premarket submission requirements. Therefore, some companies conclude that they can save considerable time and money by not performing expensive studies…But is that really true? The U.S. Food and Drug Administration (FDA) has established three regulatory classes based […]
Labquality acquires QAdvis AB
Labquality strengthens its regulatory affairs service capabilities and expands to Sweden. Labquality, supported by Mérieux Equity Partners, acquires QAdvis AB. Read the full story here!
Free Seminar – Incident Reporting/PMS – 19 June – Kista
Let’s talk about incident reporting, one of the important Post Market Surveillance activities for companies that place medical devices on the market. Information After years of development and testing, bringing your medical device to market is an exciting achievement. However, your work isn’t finished yet. Once your product is in the hands of the public, […]
Free Seminar – Incident Reporting/PMS – 13 June – Lund
Let’s talk about incident reporting, one of the important Post Market Surveillance activities for companies that place medical devices on the market. Information After years of development and testing, bringing your medical device to market is an exciting achievement. However, your work isn’t finished yet. Once your product is in the hands of the public, […]
Will AI replace your doctor?
AI enabled medical devices are increasingly making their way into every sector of the medical profession, supporting decision-making that could potentially affect life or death for patients. As these technologies improve, a pressing question emerges: Should we trust AI or the doctor? AI enabled medical devices are becoming more prevalent and powerful, raising new challenges […]