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