CE marking of smartphone-based heart diagnostics

Purpose and goal

CORAI Medicinteknik AB is developing a medical device that enables cardiac diagnostics at home using the patient´s own mobile phone as a measuring instrument. Today´s limited access to diagnostics results in long waiting times, which increases the risk of complications such as stroke. The project aims to complete the quality management system and technical documentation for the review conducted by a notified body as part of CE marking according to the MDR.

Expected effects and result

The project will deliver a completed QMS and technical documentation that meets regulatory requirements for CE marking according to the MDR. This is a prerequisite for the product to be introduced on the EU market. The company´s medical device enables accessible, cost-effective cardiac diagnostics directly at home, which will reduce waiting times, relieve healthcare services, and contribute to equitable diagnostics – even in resource-limited settings.

Planned approach and implementation

The project is carried out in collaboration between CORAI and an external expert with experience in regulatory work for similar products. The focus is on completing the QMS and technical documentation for the product. The work is conducted iteratively with continuous knowledge transfer between the expert consultant and CORAI, which both builds internal capacity for future regulatory processes and ensures that the documentation meets MDR requirements.