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.
EU Regulation 2024/1860 includes an amendment to the MDR & IVDR regarding a gradual rollout of Eudamed modules and a subsequent change in compliance timelines for manufacturers. Regulation (EU) 2024/1860, adopted on 13 June 2024, introduces significant updates to the European regulations governing the rollout of the Eudamed database, as well as the obligations related […]
Welcome Melanie and Daniel!
We are pleased to introduce two new team members who will be strengthening our efforts in the Sales Department and Quality & Regulatory Services. Melanie brings a background in Mechanical Engineering with a focus on medical devices. As a Junior Consultant, she will be a valuable addition to our team of quality and regulatory consultants. […]
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, […]