Regulatory Status

The SereneAI ECG device and software are investigational and in development. They are not approved by CDSCO or any other regulator and are not available for sale or for use in patient care.

We are developing to medical-device standards — ISO 13485 (quality management), ISO 14971 (risk management), IEC 62304 (medical software) and the IEC 60601 series (electrical safety and electrocardiographs) — and will complete clinical validation and regulatory approval in India before launch.