Join Us at NLS Days on September 18-19!
We’re excited to announce that GBA Key2Compliance will be attending NLS Days in Malmö next week. Visit us at booth B:07 to meet our team: Jan Hellqvist, Helena Dahlin, Jeanette Demorney, Terese Hedin, and Anders Jeppsson from GBA Key2Compliance, as well as Timo Lebold and Judith Richstein from GBA MDS. We look forward to connecting […]
Jeanette Demorney; the new Director of the Clinical Development business area
Medtech and Pharmaceutical consultants Key2Compliance sharpens its Clinical Development offer and recruits experienced Business Developer and Project Leader Jeanette Demorney. “I believe I can contribute with a broader way of thinking about business development within a Medtech and IVD focused CRO”, she said. Jeanette Demorney has a solid background in both the healthcare and the […]
Learn more about IVDR from the experts!
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 […]
Sustainable practices and approaches in Healthcare
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 […]
Meet us at Nordic Life Sience Days!
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 […]
IVDR brings stricter regulations for In Vitro Diagnostic medical devices
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 […]