QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
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 […]