News from QAdvis

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 […]

Importers and Distributors: Pivotal roles in MDR and IVDR Compliance

There is a common misconception that only manufacturers need to comply with the Medical Device Regulation (MDR) 2017/745 and/or the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) . However, MDR/IVDR defines the roles and the responsibilities of “Economic Operators” which includes Importers, Distributors, Authorized Representatives and Manufacturers. An Importer means any natural or […]