Standards and certifications
Our management systems comply with:
- ISO 13485: 2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 27001 Information security management systems
- ISO 14971: 2019 Medical devices - Application of risk management to medical devices.
In addition, all of our products comply with:
- IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
- IEC 62304:2006 Medical device software - Software lifecycle processes
- IEC 62304:2006 + Amd 1:2015 Medical device software - Software lifecycle processes - Amendment 1
- IEC 82304-1:2016 Health software - Part 1:General requirements for product safety
- DCB 0129 Clinical Risk Management: its application in the manufacture of health IT systems.