Key2Compliance has summarized some of the key challenges of the IVDR transition in a webinar. The webinar features expert consultants and industry professionals and helps companies understand the new regulations, and what its implementation means for them and their IVD devices. The speakers tackle various topics on the subject, ranging from key changes in the […]
Sustainability is quickly becoming one of the main focuses of the healthcare industry in Europe, with multiple legislations already in place, in addition to future measures that will further promote and require more sustainable solutions from medical companies. These legislations will extend to medical devices, with the new regulations requiring companies to take on sustainable […]
Join us at the Nordic Life Science Days on the 28-29th of September in Malmö. This is the largest Nordic partnering conference dedicated to the life science industry. Stop by at booth 26 and meet our team- Jan Hellqvist, Tomas Camnell, Susanne Søeborg, Charlotta Hjerpe, Malin Löwenhoff and Terese Hedin. Learn more about Key2Compliance and how we make complex things easier for Medical Device, IVD […]
In 2016, the European Commission decided to gradually introduce a new mandatory regulatory framework for IVDs: IVDR (In Vitro Diagnostic Medical Device Regulation). The new regulations will replace the old In Vitro Diagnostic Medical Devices Directive IVDD on May 26, 2022. We know that it can be overwhelming to get an understanding of the new […]
