Submitted to Notified Body for Medical CE Certification
The Detalo Clinical has been certified according to standards for medical devices:
IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance is an international standard that applies to the basic safety and essential performance of medical electrical equipment
IEC 62304 Medical device software — Software life cycle processes
Upon request, we can share our test certificates covering the detailed standards.
The Detalo Clinical™ has been submitted to notified body to certify that the device is fully compliant with the MDR and with the aim to place the device on the European market as a medical device.