Overview Medical Electronics

Our team spirit and many years of experience are what make us stand out

Overview Medical Electronics
 
Bizle İletişime Geçin

Quality culture and a winning team

Thanks to our one-stop solutions, you will benefit from our synergies, cost efficiencies, and vigorous quality standards and you can rest assured that your final product will be exactly what you need. And naturally, we satisfy all regulations and standards required by law with regard to the medical industry.

Certifications

Management system standards:

  • ISO 13485 Quality Management System for the Design and Manufacture of Medical Devices
  • ISO 9001 Quality Management System
  • Directive 93/42/EEC Medical Devices, Annex II
  • ISO 14001 Environmental Management Systems
  • ISO 27001 Information Security Management Systems


Product standards:

  • IEC 60601ff. Safety Standards for Medical Electrical Equipment
  • ISO 14971 Application of Risk Management to Medical Devices
  • IEC 62304 Medical Device Software
  • IPC-A-610 Acceptability of Electronic Assemblies