What are primary users? What are secondary and even tertiary users? What specific requirements do regulations place on these user types, particularly the FDA and IEC 62366? Should we talk about users, operators, or consumers? This article provides answers.
FMEA, or Failure Mode and Effect Analysis, is a procedure for investigating the unknown effects of known causes. In the case of medical devices, for example, FMEA is used in risk analysis to analyze the consequences of a faulty component, in particular, the resulting hazards.
DetailsThe process FMEA (pFMEA) is a method for the systematic analysis of risks resulting from failure modes in processes, such as device production and cleaning. Laws, such as the MDR, and standards, such as ISO 13485, require medical device manufacturers to identify and control such process risks.
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