Cue Health Receives ISO 13485 Certification
San Diego, CA—(July 3, 2018)--Cue Health Inc. (“Cue”), a healthcare technology company developing a connected diagnostics platform for professionals and consumers today announced that it received its ISO 13485 certification from British Standards Institution (BSI).
The ISO 13485:2016 standard for medical devices represents the requirements for a comprehensive management system for the design and manufacture of medical devices. The specific scope of the certification achieved is for the design and development, manufacture and distribution of in-vitro diagnostic medical devices used in the detection, diagnosis and management of infectious diseases, women’s health, cardiovascular health, wellness, and other diseases and conditions.
“The ISO certification is a fundamentally important recognition of Cue’s processes to develop and manufacture diagnostic products for medical use,” said Ayub Khattak, CEO of Cue Health Inc.
The ISO certification is an internationally recognized standard. The FDA recently announced it planned adoption of the ISO 13485:2016 standard to harmonize the Quality Systems aspect of the regulation of medical devices with the international standard.
“We are proud of the system we have built to receive this important certification for medical device development and in vitro diagnostic (IVD) manufacturing,” said Siaw-Yen Lim, Director of Quality for Cue Health Inc.
About Cue Health:
Cue Health Inc. (“Cue”) is an ISO 13485 certified company based in San Diego focused on developing and manufacturing medical diagnostic products for both professional and at-home settings. Cue’s mission is to create tools that empower physicians and consumers by increasing their access to actionable data. Cue’s first product, the Cue Health Monitoring System, is a connected diagnostic platform.