Quality

The user interface is the first thing your customers will notice about your medical device. This means that it has a huge impact on how your medical device will be received: first impressions count! Here at the human-machine interface there is a real opportunity to gain a competitive advantage and inspire your customers. And because the user interfaces from steute Meditec are reliable – in every situation and over a very long time – the second impression will also be lasting.

Simple assimilation of documentation
By integrating our hand and foot controls as components in your medical devices, you have a further benefit: we offer optional certification, validation and documentation of our user interfaces to all the relevant medical standards. This allows you to concentrate on your own key areas of competence – developing and manufacturing medical devices. We can provide you with MDR-compatible documentation which you can then assimilate in your own paperwork. This is the proof you require that all documentation, production and inspections of our user interfaces conform to the requirements set out in the medical directives. This in turn makes it far easier for you to acquire approval for the overall system – including its user interfaces.

"All inclusive"

Our QM documentation is comprehensive. Depending on the customer wishes and technologies used, it includes:

Process information

  • Process flowchart
  • Final inspection plan
  • Inspection sheet for final inspection

Risk analysis

  • Risk management (DIN EN ISO 14971)
  • Design FMEA
  • Process FMEA

Certificates, annotations, etc.

  • REACH/ROHS
  • Certificate EN ISO 13485:2016
  • Certificate IEC 60601 durch die CSA
  • Software validation (EN IEC 62304)

As an optional extra we can provide a CB certificate to IEC 60601, issued by the CSA and complying with the "CB scheme" established for electromedicine and accepted by international approval bodies.

Tried and tested in our own laboratory

Both new developments and serially produced user interfaces are tested in our fully equipped steute Meditec laboratory. Scope of testing includes:

  • Automated lifetime tests for foot controls
  • Climate chamber tests
  • Leak tests (differential pressure, water storage, high-pressure water jets)
  • Impact tests and drop tests

Additional tests, e.g. electromagnetic compatibility (EMC), are prepared and practised by steute and then conducted by independent, accredited test laboratories.

Get in touch?
Please contact us!

Maurizio Lauria
Brand Manager
steute Meditech Inc.

+1 203 2446302
maurizio.lauria@steuteusa.com