Candor registered all MDR/UDI registration
Candor has by 20. Of may 2020 registered all their products regarding MDR/UDI registration systems. This is made according to:
- EN ISO 14971:2009 Medical devices – Application of risk
- EN 62366-1:2017 Medical devices – Part: Application of usability engineering
- EN ISO 15223-2:2010 Medical devices – symbols to be used
- EN ISO 10993-1:2017 Medical devices – Biological evauation of medical devices
- EN ISO 13485:2016 Medical devices – Quality management systems