In the rapidly evolving diagnostics landscape, the In Vitro Diagnostic Regulation (IVDR) sets the benchmark for in vitro diagnostic devices within the European market. At Protavio, maintaining IVDR compliance is not just a requirement—it’s a cornerstone of our dedication to delivering reliable, high-quality, and innovative diagnostic solutions.
On November 26-27, 2024, Protavio’s QA Manager, Dr. Nikos Tsolakos, participated in BSI Group’s “Meet The Experts IVDR” event in Amsterdam. This annual gathering, tailored for professionals seeking to stay ahead in the regulatory domain, provided a platform to explore the latest updates, timelines, and best practices for IVDR compliance. The agenda included comprehensive sessions on the IVDR status quo, quality management systems under IVDR, lessons learned, submission strategies, and workshops on emerging topics like AI and software requirements, technical files, and post-certification compliance.
At the event, Dr. Tsolakos connected with leading IVDR experts to exchange insights on the evolving regulatory framework. These interactions are critical to refining Protavio’s compliance strategies, ensuring seamless alignment with the latest IVDR requirements. Backed by GMP, ISO 9001, and ISO 13485-compliant quality management systems, Protavio remains focused in its commitment to excellence.
Additionally, this event offered the opportunity to forge meaningful relationships with industry leaders and key stakeholders, fostering collaboration and encouraging the exchange of knowledge within the IVD sector.
Protavio’s participation in this event underscores our unwavering commitment to regulatory excellence and scientific innovation. Leveraging the insights and connections gained, Protavio is poised to continue providing top-tier multiplex IVD development and production services. This ensures our partners receive diagnostic solutions that consistently meet the highest standards of quality, safety, and compliance, reinforcing Protavio’s position as a trusted leader in the multiplex IVD sector.