Our HIPAX software solutions meet the high demands on medical products required by law and are cleared by the FDA to be marketed in the USA
We are TÜV certified according to Guideline 93/42/EEC (2007/47/EC) of Council of Medicine Products and maintain a quality management (QM) system in compliance with ISO 13485. Software development is carried out following EN 62304.
More than 9.000 installations worldwide prove the hight quality of our products. Our close contact to reputable hospitals and physicians enables us to ensure the up-to-dateness of our products in the future.
You find the according certificates here
"Quality is never an accident -
it is always the
result
of intelligent
efforts"
John Ruskin (1819 - 1900)
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- Steinhart Medizinsysteme GmbH matches the recommended standards of the workgroup "Arbeitsgemeinschaft Informationstechnologie der Deutschen Röntgengesellschaft @GIT"
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- Steinhart Medizinsysteme GmbH is a corporate member of the "HL7 Benutzergruppe in Deutschland e.V."
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- The products of Steinhart Medizinsysteme GmbH are cleared by the U.S. Food and Drug Administration (FDA)
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