Medical Device

The intended purpose of CanRisk is to produce risk estimates for developing breast, ovarian or prostate cancer and for carrying a relevant pathogenic gene variant using cancer family history, genetic and other risk factors

Refer to 'About' for instructions before use

This software product has been designed according to

• ISO 13485:2016
  Medical devices - Quality management systems - Requirements for regulatory purposes.
• ISO 14971:2019
  Medical Devices - Application of risk management to medical devices.
• IEC 62304:2006
  Medical device software — Software life cycle processes.