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Risk Management
We provide the expertise needed to develop and implement an ISO 14971 compliant risk management process. This process analyzes a product or process for known hazards and helps to identify unknown hazards. Identified risks are evaluated for severity, detectability and probability of occurrence. Risks that fall into an unacceptable level are then further evaluated for possible mitigations. Once mitigations are selected, the unacceptable risks are then re-evaluated. Any risks that remain unacceptable are then presented to management for a business decision to proceed or not to proceed.
This process can be applied to both new and existing products and processes. The risk management process provides a documentation trail that identifies hazards, how the risks are evaluated, the mitigations considered and implemented, and the success of the mitigation. This process lays a documented structure, continual evaluation, and improvement for a product or process during its’ life cycle.
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