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Following ISO 14971 and IEC 62366-1

Risk management is a multidisciplinary exercise. It requires knowledge of the product design characteristics, manufacturing process, intended use, claims, mode of action as well as a deep understanding of the application of standards ISO 14971 and IEC 62366-1 which provides the rules for the risk management process including usability risk management. We have an extensive experience in risk assessments and we use dedicated tools which support systematic analysis, assessment and process compliance. We excel in coordinating risk management processes and in writing and organizing the resulting documentation in a way that ensures traceability to product, usability, general safety and performance requirements and specifications.

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