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In the high-stakes world of medical device manufacturing, thorough risk analysis isn’t just good practice—it's a compliance necessity. Process Failure Mode and Effects Analysis (PFMEA) is a key method used to systematically identify and control potential failures in production processes. Regulatory frameworks (like EU MDR and ISO 13485) require manufacturers to assess and mitigate these process risks from the outset. The reason is simple: when lives are on the line, no failure mode can be overlooked.