Analysis of hazards related to the intended use of the software device is a mandatory part of the documentation.
Such hazards can result from software functions which are encoded in the device, from hardware configuration and also from inadvertent misuse.
Device features which are managed by software are especially important for this analysis. In most cases, this forms part of a wider risk management summary for the medical device, with ISO 14971 as the international reference standard and IEC/TR 80002-1 as specific guidance for the risk assessment of medical device software.
GEMARMED has extensive experience of risk management throughout the industry over many years, and are skilled in working with device manufacturers to identify and document
  • Hazardous events associated with use of the device

  • Cause and severity of the hazard

  • Control methods (such as alarms & warnings, new design, algorithms, security functions)

  • Risk mitigation to acceptable levels

  • Verification of risk reduction and control methods

  • Validation of the final system

The analysis of potential software failures is a specialised skill, designed to improve the safety and performance of your device. Contact us for assistance in this essential endeavour.