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Digital Heart monitor

COALA BLOG

News from Coala

This is where we share what’s happening at Coala Solutions – news about our products, research collaborations, milestones along the way and stories from the healthcare providers we work with. Follow along as we continue building the future of connected cardiac care.

MILESTONE

Coala Solutions certified under the EU Medical Device Regulation (MDR)

Coala Solutions AB has received its EU quality management system certificate under the MDR (EU) 2017/745, issued by the notified body BSI. The certificate covers active non-implantable devices for monitoring vital physiological parameters in risk class IIa, and means that Coala Solutions is now the manufacturer of the Coala Heart Monitor.

On 29 October 2026, BSI (Notified Body no. 2797) issued an EU certificate for Coala Solutions’ quality management system under Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR). The certificate number is MDR 825129, and it is valid until 28 October 2031.

The certification is based on BSI’s assessment of Coala Solutions’ quality management system in accordance with Annex IX, Chapters I and III of the MDR. It covers active non-implantable devices for monitoring vital physiological parameters in risk class IIa. To keep the certificate valid, BSI follows up on our quality work through recurring audits.

With this certification, Coala Solutions AB is the manufacturer of the Coala Heart Monitor. The device was previously CE-marked via Coala Life AB, with Coala Solutions as an approved distributor.

“This certification is an important step for us and a confirmation of the quality work we do. It gives us a strong foundation to continue developing and delivering the Coala Heart Monitor as a support for healthcare,” says Magnus Sörlander, CEO of Coala Solutions.

The Coala Heart Monitor is used in healthcare to record ECGs and provide information that can support the clinician’s assessment. For healthcare providers already using Coala, the certification does not change anything in their day-to-day work.

The certificate can be verified with BSI on request.

RESEARCH

Listening to the heart in new ways: Coala in the Swedish–Norwegian research project FUSMON

Coala Solutions is a partner in FUSMON, a three-year Interreg Sweden–Norway project. Together with Mid Sweden University, NTNU and CATE Medical Devices, we are exploring how AI can combine heart sounds and ECG to give a richer picture of heart health.

Coala Solutions is a partner in FUSMON, a three-year research project funded by Interreg Sweden–Norway. Together with Mid Sweden University, NTNU and CATE Medical Devices, we are exploring how AI-based sensor fusion can give a richer picture of heart health.

The heart communicates in more than one way. An ECG captures its electrical activity, while heart sounds reveal how it works mechanically. Today these signals are usually analysed separately. In FUSMON, we want to find out what happens when they are combined.

Coala’s part of the project focuses on bringing heart sound and ECG data together using AI. The work is carried out in close collaboration with researchers at Mid Sweden University, combining their expertise in sensor systems and signal processing with Coala’s ten years of experience in recording both signals simultaneously.

The goal is to build knowledge that, in the long run, can support earlier detection and better assessment of heart conditions, closer to where patients live.

FUSMON runs for three years and brings together academia and industry from both sides of the Swedish–Norwegian border. We look forward to sharing more as the project progresses.

Further reading (in Swedish)

MILESTONE

ISO 13485 certified: a quality milestone for Coala Solutions

Coala Solutions has been certified to ISO 13485:2016 – the international standard for quality management systems for medical devices – following an independent audit by BSI.

Coala Solutions has been certified to ISO 13485:2016, the international standard for quality management systems for medical devices. The certificate was issued by BSI and covers the design, development, manufacture and distribution of cardiac monitoring systems.

ISO 13485 sets out the requirements for how medical device companies work with quality, from design and development to manufacturing, distribution and follow-up. The certification confirms that our quality management system meets these requirements, following an independent audit by BSI.

Quality and patient safety are at the core of everything we do. This certification is the result of structured, long-term work by our whole team, and it gives healthcare providers confidence in how we develop and deliver our solutions.

The certificate (no. MD 824885) is effective from 18 September 2026 and can be verified in BSI’s Certificate Directory: www.bsigroup.com/ClientDirectory.