1. FMEA and its variations. When an FMEA has its failure modes prioritized according to their importance, the process is called failure modes, effects, and criticality analysis (FMECA). When an FMEA ...

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Effective occupational health and safety management requires a structured approach to hazard identification and risk assessment, which is best achieved by a management system. The implementation of an ...

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In the context of ISO 14971:2019 1 and risk management for medical devices, manufacturers and designers are often confused about the implementation of hazard analyses and FMEAs (failure modes and ...