News
Obtaining the Quality Management System certificate EN ISO 13485:2016
May 20, 2021
On May 20, 2021, the Company received the Quality Management System CERTIFICATE EN ISO 13485:2016 issued by the notified body TÜV Rheinland.
Obtaining an EC certificate confirming compliance with Directive 93/42/EEC for Medical Devices.
May 20, 2021
On May 20, 2021, the Company received the EC certificate – Full Quality Assurance System, Directive 93/42/EEC for Medical Devices, Annex II, excluding Section 4,
Completion of laboratory tests
April 19, 2021
On April 19, 2021, tests of the CARDIOVICE ECG Recorder product together with the CARDIOVICE App software for compliance with Directive 93/42/EEC for Medical Devices were completed.
