ISO 13485:2016 clause 7.1 requires that risk management process for all product realization processes has to be implemented before a medical devices has been put on the market. Due to the fact that ISO 13485 references ISO 14971, implementation of this standard by the organization emerges as the most appropriate solution to ensure the risk management requirement of ISO 13485. Within the 2016 revision of ISO 13485, risk management has been referenced nearly in all product realization clauses. Therefore the importance of risk management will increase in the coming years parallel to the revisions of the regulatory requirements.
The informative annexes of ISO 14971 includes very useful examples for the application of a risk management process, particularly for hazard identification and risk assessment, which are considered as the heart of a successful risk management process.
ISO 14971 defines the risk management process mainly with the following steps;
- Risk Analysis
- Risk Assessment
- Risk Control
- Risk-Benefit Analysis
- Risk Management Reporting
- Review of the Risk Management and PMS
These main steps shall be implemented with the classical plan, do, check, act cycle. The risk mitigation (risk control) measures shall be evaluated in the loop as the main criteria for a successful implementation of ISO 14971.
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