Furthermore all devices are certified CE and are accordant to the European regulations in force.

Electro medical test – photo biological test – etc ISO 13485 Quality Management System for Medical Devices is a quality management system standard specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements. ISO 13485: 2016 has been harmonized against the three EU Medical Devices Directives (Medical Devices, in vitro Diagnostic Devices and Active Implantable Devices), so certification to this standard by an accredited certification body such as EMC automatically demonstrates compliance with specific clauses in these directives.

The certification of a quality management system, specifically for medical devices, to ISO 13485 is essential, for medical companies which export their products to the global market.  

In the European Union, the fulfillment of EU. Directives (e.g., Active Implantable Medical Devices Directive, Medical Devices Directive and in vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU directive requirements is the establishment and independent assessment of the quality system.