IMPLEMENTATION OF RISK MANAGEMENT FOR MEDICAL DEVICES

....cont'd

RISK MANAGEMENT FILE

The ISO 14971 standard lists the records required for the management file and include:

Risk Management Plan
Identification of hazards
Estimation of risks
Risk Evaluation (risk acceptability)
Measures for control
Evaluation of effectiveness
Risk Management Report (risk management results recorded)
Verification

THE RISK MANAGEMENT PROCESS

As stated earlier on the Risk Management Process consists of:

Risk Analysis
Risk Evaluation
Risk Control
And Post production Information

CONCLUSION

ISO 14971 provides an excellent framework of defining the different elements of the Risk Management process of medical devices. When implemented properly the standard will assist manufacturers in effectively reducing risk and will ensure products are created safe and effective.

END

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