ISO 14971 makes an overview of the risk management process. The standard is intended to be used as part of a quality system, but could be used where a quality system is not in place. ISO 14971 specifies a procedure for the manufacturer of a medical device or in-vitro-diagnostics. Read the following page for further information about the risk management according to ISO 14971
- Identify hazards associated with medical devices and
its accessories
- Estimate and evaluate the risk associated with those hazards
- Control those risks
- Monitor the effectiveness of that control
Conformance to the standard requires the points
- Establish a risk management process
- Policy on acceptable risk
- Reduce risk on design process
- Conduct a final risk benefit analysis and provide information on residual
risk
- Fault Tree Analysis
- Hire and train qualified personnel
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ISO 14971
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Actual information as download
about risk analysis according to ISO 14971
Risk management - Severity - Likelihood
