The International standard specifies a process for a manufacturer to identify the hazards associated with the Medical Device, including in vitro diagnostic ( IVD) Medical Device, to estimate and evaluate the associated risk, to control these risk and monitor the effectiveness of the controls. ISO 14971 is the standard that describes the application of risk management.The requirements of this International standard are applicable to all stages of the life cycle of a Medical Device. In case of CE Marking the risk assessment portion is mandatory.
The steps involved in the Risk Management are,
- Intended use and identification of characteristics related to safety of the Medical Device
- Identification of Hazards
- Estimation of the risk for each hazardous situation: The risk estimation is done for each of the foreseeable hazards and charted in a table. Consider the check lists for risk estimation.
2. Risk Evaluation
3. Risk control
- Risk control option Analysis
- Implementation of Risk control measures
- Residual risk evaluation
- Risk arising from risk control measures
- Competence of Risk control
4. Evaluation of Overall residual risk acceptability
5. Risk Management Report
6. Production and post production information
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