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Risk management during the entire device development cycle is a mandatory requirement domestically as well as internationally. The implementation of risk management on procedural and operational level does not have to impose an additional burden. If correctly applied,. risk management ensures a more efficient development process and reduces product life-cycle cost.

System Safety,Inc.  has extensive experience in implementing streamlined risk management processes. Depending on your already established operating procedure framework we are able to integrate a compliant risk management lifecycle into your development process.

bulletExample of a partial IEC 601-1-4 risk management checklist in (HTML) or (PDF)
bulletExample of a partial ISO 14971 risk management checklist in (HTML) or (PDF)

For more information see Methodologies :: Risk Analysis

 

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