On May 20, 2021, the Company received the Quality Management System CERTIFICATE EN ISO 13485:2016 issued by the notified body TÜV Rheinland. The certificate covers the design and development, production and distribution of ECG signal recorders with dedicated software and equipment. The certificate is valid until January 28, 2024.
The issuance of the certificate has been confirmed by an extensive audit and confirms the high competence of quality management by Telemedical Innovations Sp. z o.o., as a manufacturer of medical devices.