• ​HiX offers you a high-quality product which complies with the European guideline Medical Device Directive 93/42/EEC MDD (in transition to MDR over the coming years).  HiX is classified as a medical device class IIb and certified as such.  The ChipSoft quality system is certified for ISO 13485:2016. 

    In our processes we comply with leading edge national and international requirements and standards, including: 

    •       EN ISO 14971:2012 - Medical devices - Application of risk management for medical devices 
    EN-IEC 62304:2006+A1:2015 - Software for medical devices - Processes in the life-cycle of software 
    EN-IEC 62366-1:2015 + EN-IEC 62366-1:2015/C11:2016 - Medical devices - Application of usability engineering of medical devices. 
    Meddev 2.12/1 rev.8 - Guidelines on a medical devices vigilance system 
    EN-ISO 15223-1:2016 (Cor.  2017-04) - Use of symbols in labelling of medical devices. 
    EN 1041:2008+A1:2013 - Information supplied by the manufacturer with medical devices. 

    XIS certification and NEN standards  

    In addition, ChipSoft is XIS-certified by VZVZ (the Association of Care Providers for Care Communication).  With this certification, HiX may be deployed as part of a well-managed care system for national message exchange via the National Exchange Point (LSP).  With this, HiX offers care institutions a solid foundation for meeting the relevant NEN standards (including 7510 and 7513).  


    • Guaranteed integration of applicable laws and regulations in HiX 

    Support for obtaining NEN standards 

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