Risk Management is not explicitly called out in the 21CFR820, however it is mentioned in the Design Control Guidance. Note that the FDA usage of “Risk” is in the sense of “Hazard” (safety, or product risk), not the more typical usage in Systems Engineering of project risk.

Clearly it is very important to manage the hazards associated with any system, in particular medical devices. The work's nature varies considerably depending on the nature of the device being developed

References

• FDA Design Control Guidance for Medical Device Manufacturers:
  • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm
  • PDF available on that page: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf
• Section 820.30 of FDA Quality System Regulation
• ISO 9001:1994

Mapping

The following process elements satisfy this objective:

• Perform Safety and Reliability Analysis
• Update Dependability Analysis
• Safety Czar
• Fault-Tree Analysis
• Hazard Analysis

More information:

• Practice: Safety and Reliability Analysis