Quality Management

Health is matter of confidence. That is conscious to us. In order to fulfil this high responsibility, we have set the quality management and the desires of our customers to the first place within astraia and into the center of our work. We develop our products with largest care and experience. Indications of this claim of quality and sense of responsibility are the following certificates/standards, which astraia and its products fulfil:

  • All astraia products are manufactured according to the CE standard and carry the CE mark.
  • The product "astraia software for women's health - obstetric and gynaecological database application" fulfils the requirements of the EC directive 93/42/EEC for medical devices, appendix II. The software belongs to the class IIa.
  • The astraia software gmbh is ISO 13485:2003 certified.

Technical standards of astraia products

  • DIN ISO 13485:2003
  • DIN ISO 14971
  • DIN EN ISO 60601-1-4 (DIN EN 62304)
  • DIN EN ISO 1045
  • DIN EN 980
  • DIN EN 591

CE Mark

CE Mark
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