Device Hazard Analysis document is to identify and assess both software and hardware hazards associated with the intended use of the medical device and should be included with premarket submission for all software devices. Risk analysis, evaluation, and control should be performed as per ISO 14971:2019 and documented.
The following information should be included:
- Identification of each hazardous event
- Cause and severity of hazards
- Risk control methods
- Any corrective actions taken
- Verification of the risk controls