We’re proud to announce that Lynsight has successfully renewed its ISO 13485:2016 certification, reinforcing our commitment to the highest standards in quality management for medical devices. This achievement reflects our dedication to excellence in every aspect of our work—from product development to patient impact.
The certification confirms that Lynsight’s quality system complies with the rigorous requirements of ISO 13485:2016, the globally recognized standard for quality management systems in the medical device industry. It also paves the way for the US market entry, where the regulation is moving from the current Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) in an effort to harmonize US regulation with the international ISO standards for medical devices.
This certification covers our core function: Design and development of in vitro diagnostic medical devices to detect hereditary cancer susceptibility.
DiagMMR, our validated test for Lynch syndrome, provides clear, reliable results to support timely and confident clinical decisions. Obtaining ISO 13485:2016 certification underscores our commitment to building safe, effective, and compliant solutions that meet global regulatory expectations.
“Our personnel’s commitment to high quality standards enabled us an easy renewal of the certificate. We have been able to build these standards into our daily operations, which emphasizes the efficiency of the Quality Management System. I believe that maintaining these standards will serve as a strong basis in our plan towards QMSR compliance and US market clearance.” – Jaana Putula, Lynsight Quality Manager
As we continue to expand access to our diagnostic solutions, this certification serves as a strong foundation for future innovation and growth. We’re proud to uphold the standards that help bring greater trust and clarity to hereditary cancer diagnostics.
About Lynsight
Lynsight provides reliable Lynch syndrome diagnostics to empower families and healthcare professionals to make better informed decisions for cancer prevention. Learn more about us here.
