ISO 13485

ANN ARBOR, Mich., Sep. 20, 2022  — Fifth Eye™, a leading provider of intuitive real-time clinical analytics including the AHI System, today announced that its Quality Management System (QMS) has received Medical Device Single Audit Program (MDSAP) certification after a rigorous audit by Intertek. 

MDSAP is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Fifth Eye’s MDSAP certification ensures the QMS conforms to the requirements of ISO 13485:2016, the US FDA regulations 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D) and the Canadian Medical Devices Regulations – Part 1- SOR 98/282.

“ISO/MDSAP certifications emphasize a key quality milestone,” said Jen Baird, CEO of Fifth Eye. “Hospitals rely on us to provide unique and valuable information to help overburdened clinicians reduce preventable adverse events and increase hospital efficiency. These certifications enhance reliance and trust in the AHI System, and positions the AHI System for use in international markets in the future.”

About Fifth Eye Inc.

Fifth Eye Inc. is an Ann Arbor, Michigan-based company that develops intuitive, real-time clinical analytics based on physiologic waveforms to improve outcomes and reduce costs. The AHI System™ is the first and only FDA-cleared clinical decision support software that continuously predicts the risk of hemodynamic instability earlier than vital signs. AI-powered AHI extracts information embedded in a Lead II ECG signal alone – no manual or other inputs required. Fifth Eye’s machine-learning technology is licensed from the University of Michigan. For more information, please visit