B-Secur Receives ISO 13485:2016 Certification

B-Secur, a global leader in biosensing algorithms, today announced that it has received ISO 13485:2016, the Quality Management System (QMS) for medical devices.

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Alan Foreman (R), Chief Executive of B-Secur, pictured with Cameron Moore (L), Quality Manager. (Photo: Business Wire)

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.”

About B-Secur

Founded in Belfast, Northern Ireland, B-Secur currently employs over 70 people across the U.S., the UK and Ireland. A leader in electrocardiogram (ECG) algorithm solutions, we are on a mission to save and improve millions of lives each year by advancing heart health technology. Combining our expertise in ECG with decades of experience in hardware, software and material science enables our partners to significantly reduce development time to market for their next-generation medical and consumer devices. For more information visit www.B-Secur.com or follow @B-Secur on Twitter & X.

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