CardioSignal Receives MDR Class IIb Certification And Unveils An Upcoming New SDK Partnership Model
We are proud to announce that CardioSignal has been certified as a Class IIb medical device under the European Medical Device Regulation (EU MDR). This achievement marks a significant milestone in our ongoing work to deliver safe, high-quality, and clinically proven medical software to the European market.
The EU MDR sets a higher bar for medical device certification than the earlier MDD framework. Achieving Class IIb status under MDR confirms that CardioSignal meets strict requirements for clinical validation, quality management, and regulatory compliance. It also positions CardioSignal among the most robust and trustworthy digital health solutions available today.
A new way for partners to integrate CardioSignal
In parallel, we are preparing to introduce something new for our partners: CardioSignal Inside, our SDK integration model.
With CardioSignal Inside, B2B partners can integrate our CE-marked atrial fibrillation (Afib) detection and heart rate measurement directly into their own mobile applications as native features. This enables them to offer medical-grade Afib detection within their own app, without needing to develop a separate product or go through their own medical device certification.
Key benefits for our partners
By embedding CardioSignal Inside:
Partners can bring certified Afib detection to market faster and more cost-effectively
No need to build, certify, and maintain a separate regulated product
Regulatory responsibility remains with CardioSignal as the legal manufacturer
The feature can be used flexibly in any patient or user pathway the partner wants to support
Users access medical-grade Afib detection seamlessly inside the partner’s app
If you are interested in offering CardioSignal’s proven technology to your users through your own digital platform, we would be happy to discuss partnership opportunities. Contact us to learn more about how CardioSignal Inside can bring value to your service.