Systems Engineering
Risk Management and Hazard Analysis
According to the ISO 14971 standard for medical devices, all medical products require a risk analysis, and this is a core function of our systems engineering group. At KMC Systems, risk management is a continuous process that starts at the onset of the product design project and carries through development into production and post-market phases. Hazard and risk analysis includes techniques such as Failure Mode Effects and Criticality Analysis (FMECA or FMEA) and Fault Tree Analysis (FTA).
Our systems engineering team is well-versed in both system and software analysis. With a thorough understanding of the end use of the medical systems we design, we can rapidly identify any potential safety or use error risks. Then, using industry-recognized processes, we create risk control measures to intelligently mitigate these risks. Our detailed risk management process and risk/hazard analyses meet the requirements of the FDA’s Quality Systems regulation and relevant International standards.
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