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Biosensing Algorithm Company B-Secur Earns ISO 13845:2016

The company said the achievement marks a significant milestone for its FDA cleared HeartKey technology.

Katie Hobbins

January 5, 2024

1 Min Read
Alan Foreman and Cameron Moore
Image courtesy of Business Wire

B-Secur, a company focused on biosensing algorithms, recently announced it has received ISO 13485:2016, the quality management system for medical devices.

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,” said Cameron Moore, Quality Manager of B-Secur, in the press release announcing the milestone.

ISO 13485:2016 specifies “requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements,” according to the ISO website. “Such organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.”

The company said the achievement marks a significant milestone for enabling accurate electrocardiogram (ECG) signal monitoring for early observation of cardiovascular disease using its FDA cleared HeartKey technology. HeartKey is a suite of ECG algorithms and analytics providing accurate levels of rhythm recognition and reduction of ECG signal noise. The technology can be implemented to run on a device or on the cloud to drive preventive and proactive healthcare management, according to B-Secur.

“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,” said Alan Foreman, Chief Executive at B-Secur, in the release.

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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