A New ISO Standard for IVD Performance Evaluation Is Taking Shape
Performance evaluation is central to demonstrating conformity under the EU IVDR. To date manufacturers have typically established their performance evaluation frameworks by drawing on the Regulation, MDCG guidance and several standards addressing individual parts of the evidence lifecycle. A new ISO project, currently under development, may eventually provide a more consolidated international reference for performance […]
IVDR Compliance Deadline – Are You Prepared?
The IVDR compliance deadline is here! If you’re a manufacturer, it’s crucial to ensure your Quality Management System (QMS) is compliant and your IVDR application is submitted to a Notified Body. For Class D IVD manufacturers, this includes submitting the application and getting a written agreement with a Notified Body by September 26, 2025. Ensuring […]
How ISO13485 prepares your IVDR Quality System for audits and what it doesn’t cover
Register today! May 27, 2025 10:30 – 11:15 CET Join our Free Webinar on IVDR Compliance for In Vitro Diagnostic Medical Device Manufacturers With the upcoming IVDR compliance deadline at the end of May, it’s crucial to ensure your organization is fully prepared. This webinar will provide a comprehensive overview of the most critical aspects […]
Navigating IVDR Certification: Prostatype’s Success Story with GBA Key2Compliance
Prostatype Genomics is at the forefront of precision medicine, offering the Prostatype® test—a groundbreaking genetic diagnostic tool designed to assess the aggressiveness of prostate cancer. By providing crucial insights, Prostatype helps clinicians and patients make informed treatment decisions, ultimately improving patient care and optimizing healthcare resources. Prostatype has an ability to significantly improve the quality […]
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 […]