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Thursday January 4th, 2024

B-Secur Receives ISO 13485:2016 Certification

B-Secur today announced that it has received ISO 13485:2016 certification, the Quality Management System (QMS) for medical devices.

This marks a significant milestone for the company in its mission to enable accurate ECG signal monitoring for early observation of cardiovascular disease, driving preventive and proactive healthcare management.

B-Secur’s FDA cleared HeartKey® technology is a suite of powerful ECG algorithms and analytics that provide highly accurate levels of rhythm recognition and reduction of ECG signal noise. Ideal for both medical and non-medical applications, HeartKey® can be implemented to run on device or on the cloud.

Cameron Moore, Quality Manager, B-Secur says; “ISO 13845:2016 certification reflects B-Secur’s dedication to quality and further confirms to customers our commitment to continuous improvement, along with the safety and effectiveness of our technology.

Alan Foreman, Chief Executive, B-Secur, says; “We are incredibly proud of the whole team who have worked hard to achieve this certification which expedites the deployment of our medical device software globally.