Risk Management

Risk analysis, including hazards list and associated risk control measures, aligned with ISO 14971 risk management processes.

ISO 14971 Risk Management

CriTech provides a complete set of documentation that captures the results of the software risk analysis, including the software hazards list and associated risk control measures, the set of fault trees with identified Single Points of Failure (SPOFs), and recommendations for mitigating the SPOFs. A traceability matrix links the software risks to their associated test cases and test results.

CriTech’s software risk management meets the applicable requirements of ISO 14971 risk management process.

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We are ready to assist in getting your medical device software compliant and can start at any point during your life cycle process!

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San Jose, Costa Rica

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San Rafael of Escazu
San Jose, Costa Rica

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