ISO/IEC International Standards
- ISO 13485:2016 ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 14971:2019 ISO 14971:2019 - Medical devices - Application of risk management to medical devices
- IEC 62304:2006+AMD1:2015 IEC 62304:2006+AMD1:2015 - Medical device software - Software life cycle processes
- IEC 62366-1:2015+AMD1:2020 IEC 62366-1:2015+AMD1:2020 - Medical devices - Application of usability engineering to medical devices
- ISO 20417:2026 ISO 20417:2026 - Medical devices - Information to be supplied by the manufacturer (2nd edition)
- IEC 60601-1:2005+AMD1:2012+AMD2:2020 IEC 60601-1:2005+AMD1:2012+AMD2:2020 - Medical electrical equipment - General requirements for basic safety and essential performance