Kardinero Medical Systems Inc.

Kardinero is a company that develops and manufactures medical devices, including diagnostic and therapeutic software applications, wearables, and AI solutions. We have over 30 years of experience in developing and manufacturing PC-based ECG and ECG Stress Test systems hardware and software, and their clinical applications.
Currently, we are developing a new Bluetooth product family, which includes BLE ECGs and multiparameter ambulatory devices designed for use in clinical settings and telemedicine applications. Our ongoing projects are now at TRL 5-6, reflecting their readiness for validation in relevant environments and near-market applications. Our expertise spans:

•           Medical electronic equipment design and R&D
•           Embedded systems and PC-based medical equipment/software
•           ECG signal analysis programs
•           Medical device quality management and certification
•           Clinical applications and partnerships with cardiology and rehabilitation clinics for clinical trials and health services research
•           Big data with availability in ECG Stress Test systems and ECG records of our devices in use
•           Regulatory processes; MDR and ISO 13485 certifications
•           Flexibility on systems and software integration with devices and programs.

We have opportunities for collaboration with technical and medical universities. Our company has extensive experience in medical electronic equipment design, R&D, PC-based medical equipment and software, embedded design, clinical applications, and medical device quality management and certification.

We have participated in several national and international projects and actively collaborate with academia. Additionally, we work closely with the Ankara University Faculty of Medicine- Cardiology and Rehabilitation Units for clinical trials and research, which further strengthens our capacity for impactful collaborations.

We are also experienced in the HORIZON projects, our actual participation is in EnTrust Project, which aligns with the Cybersecurity Act and the guidance on cybersecurity for medical devices. Especially, experienced in integrating new scenarios into our programs and devices and testing to ensure seamless functionality and reliability.