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We live on our experience

Looking at the term 'biomedical technology', one might sometimes forget what it is all about: the lives of individual people. This is why the regulatory requirements are so high and subject to continuous updates.

We are commited to 'Engineering for People' and in our development projects we are well aware that the safety of our products must comply with all internal, external and regulatory standards. We help you fulfil manucaturer and operator obligations by providing transparently structured documentation including risk management, thorough product verification at all stages, serviceability and maintainability.

We know what it means to have a product on the market, plus we have many years of experience both as a developer on the industry side as well as a manufacturer of cardiac devices. Our industry expertise in biomedical technology is also benefiting from the close cooperation with various universities. Sometimes it even happens that we can inform our customers about changes in legislation before they have heard of them.

  • Audit-safe documentation
  • EN ISO 13485
  • EN ISO 14971
  • EN 62304
  • EN 60601
  • EMC up to 600 V/m