Michael Barbella, Managing Editor03.14.24
B-Secur has received ISO 13485:2016 certification, the Quality Management System (QMS) for medical devices.
The certification 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 u.S. Food and Drug Administration-cleared HeartKey technology is a suite of powerful ECG algorithms and analytics that provide highly accurate levels of rhythm recognition and reduce ECG signal noise. Ideal for both medical and non-medical applications, HeartKey®can be implemented to run on device or on the cloud.
“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,” B-Secur Quality Manager Cameron Moore said.
HeartKey 2.0 offers universal performance across EKG use cases including Holter monitors, wearables, and implantable devices. The technology refines and enhances signal clarity enabling EKG clinicians to make faster and more accurate diagnoses. The product's increased signal performance and accuracy improves EKG interpretation, reducing the potential for false positives and the requirement for expensive repeat testing, according to the company. This in turn drives greater medical and financial efficiencies as more patients can be monitored and treated.
“We are proud of the whole team who have worked hard to achieve this certification which expedites the deployment of our medical device software globally," B-Secure CEO Alan Foreman stated.
Founded in Belfast, Northern Ireland, B-Secur currently employs more than 70 people in the United States, U.K., and Ireland. A leader in electrocardiogram (ECG) algorithm solutions, the company combines expertise in ECG with decades of experience in hardware, software and material science to help customers significantly reduce development time to market for their next-generation medical and consumer devices.
The certification 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 u.S. Food and Drug Administration-cleared HeartKey technology is a suite of powerful ECG algorithms and analytics that provide highly accurate levels of rhythm recognition and reduce ECG signal noise. Ideal for both medical and non-medical applications, HeartKey®can be implemented to run on device or on the cloud.
“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,” B-Secur Quality Manager Cameron Moore said.
HeartKey 2.0 offers universal performance across EKG use cases including Holter monitors, wearables, and implantable devices. The technology refines and enhances signal clarity enabling EKG clinicians to make faster and more accurate diagnoses. The product's increased signal performance and accuracy improves EKG interpretation, reducing the potential for false positives and the requirement for expensive repeat testing, according to the company. This in turn drives greater medical and financial efficiencies as more patients can be monitored and treated.
“We are proud of the whole team who have worked hard to achieve this certification which expedites the deployment of our medical device software globally," B-Secure CEO Alan Foreman stated.
Founded in Belfast, Northern Ireland, B-Secur currently employs more than 70 people in the United States, U.K., and Ireland. A leader in electrocardiogram (ECG) algorithm solutions, the company combines expertise in ECG with decades of experience in hardware, software and material science to help customers significantly reduce development time to market for their next-generation medical and consumer devices.