Solution Provider for Medical Electronics

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

Solution Provider for Medical Electronics
 
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“Expertise under one roof” – a winning team for you and your medical technology

By working together closely, we can achieve ambitious goals – yours and ours
One factor that is especially important in our day-today business, and one that we actively cultivate, is how we interact. How we network with our customers and suppliers. Collaborating closely with our customers and partners at every stage in the value chain allows us to transform your ideas and your very specific solutions into the highest-quality products. And in the process we create a crucial advantage for you in your own competitive environment.

 

We implement your ideas in the medical industry – while keeping our eye on the entire value chain
Our key factors for success are the outstanding quality of our products and services as well as our highly qualified and motivated employees. We foster a quality culture that does not rely on past successes but is continuously realigned with the needs of today through a process of ongoing improvement. And naturally, we satisfy all regulations and standards required by law with regard to the medical industry.

 

Certification – Management system standards

  • ISO 13485 Quality Management System for the Design and Manufacture Medical Devices
  • ISO 9001 Quality Management Systems
  • Directive 93/42/EWG Medical Devices Directive, 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