Augurex Achieves MDSAP Certification

Vancouver, BC – August 22, 2024 – Augurex Life Sciences Corp., a leader in biomarker-driven diagnostic solutions for the detection and management of autoimmune diseases, today announced its successful certification under the Medical Device Single Audit Program (MDSAP). This milestone reinforces Augurex’s commitment to the highest quality and regulatory standards in North America and across global markets.

MDSAP certification, overseen by International Medical Device Regulators Forum member countries (US, Canada, Australia, Brazil, Japan), as well as the official Observer and Affiliate countries around the world, allows for a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple jurisdictions. This comprehensive certification enables Augurex to streamline its regulatory processes and expand the global reach of its proprietary 14-3-3η biomarker and auto-antibody platforms for the diagnosis and management of autoimmune diseases, such as rheumatoid arthritis and axial spondyloarthritis.

“Achieving MDSAP certification is a significant accomplishment that reflects our dedication to maintaining the highest level of quality in every aspect of our operations,” said Neil Klompas, CEO of Augurex. “This certification enables us to accelerate our international growth while ensuring that our products continue to meet rigorous global regulatory and quality standards. Moreover, MDSAP certification plays a key role in our commitment to creating access to our diagnostics for patients and their physicians around the world.”