IMPLEMENTATION OF RISK MANAGEMENT FOR MEDICAL DEVICES

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WHAT IS RISK MANAGEMENT?

Risk management covers many pieces of the risk puzzle, including:

Risk assessment
Risk estimation
Risk evaluation
Risk analysis
Risk control
Hazard identification
Hazard estimation

The 4 step process for ensuring safety and effectives which forms the basis for this standard is: identify the hazard; estimate the risk; determine the acceptability and mitigate the risk. The standard does handle more that just the process though. For instance the guidance also includes information for developing your Risk Management File and for dealing with post market information.

ISO 14971’s risk management process takes us through the entire medical device lifecycle from quality planning through to design transfer activities. This progression demonstrates how the risk process “collects” information regarding risk then “disseminates” this information back (to make the devices safer).

Collection Processes:

Quality Planning

Develop risk management plan
Identify hazards
Estimate risks
Validation (compile Risk Management File)

Dissemination Processes:

Design Input (catalog the risks desired to be reduced)

Design Output (reduce the risks)

Design Verification (overall risk evaluation)

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