Medical

Quality Management System meets ISO 13485:2012 requirements.

About

As the customer and the standards require we are responsible for special medical requirements such as Device Master Record (DMR), Device History Record (DHR) and Traceability. 

 

In 2015 we have been awarded with product industrialization of IPL device including:

 

  • assembly line design and set-up, assuring tracebility, DHR, line release, SW validation...
  • production in clean room environment
  • performing special safety tests such as high voltage tests, critical component tests...
  • calibration devices for energy, Skin Detector sensor (SDS), Skin Tone Sensor (STS)...
  • EOL control devices for flashing power measurement, SDS control...