Quality is our first priority. That's why we ensure the reliable use of our products and ensure compliance with all legal requirements. syngo.share as a medical device is subject to special regulations, which are reviewed regularly. Our quality management system is developed and reviewed in internal and external audits.  

Certificates

  • EN ISO 9001
  • EN ISO 13485
  • MDD 93/42/EEC

Standards

  • IHE Integration Statement
    IHE (Integrating the Healthcare Enterprise) is an international initiative aiming to improve the interoperability of information systems in healthcare systems since 1997. Specifically, the aim is that computer systems from different vendors should provide a common minimum standard for the cooperation. The IHE publishes the framework of standards (technical frameworks) as guidelines for the cooperation and the interoperability of different information systems.

    Our products meet the relevant IHE specifications for health networking (virtual electronic patient records, electronic health cards) and are tested regularly for IHE Connectathons.

    For a listing of profiles validated and tested by the IHE profiles for our products:

    for eHealth Solutions

    for Archiving Solutions

     

  • EFA - electronic case file
    With EFA, a data protection-compliant interoperability in the healthcare sector is set. EFA interfaces are intended to ensure a smooth flow of information - format-independent. Our product eHealth Solutions is EFAv2.0 compliant tested.
    The certificate of conformity can be found here.