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Reliability Engineering in Biomedical Systems
Methodologies and practices for the safe development of ventricular assist devices. DE
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Reliability engineering in medical devices plays an important role in ensuring that equipment used in diagnostics, therapies and monitoring functions safely and with constant performance throughout its entire life cycle. Its focus is to identify, prevent and mitigate failures that could affect clinical efficacy or patient safety.The process ranges from design - with fault tree analysis (FTA) and accelerated testing - to production, maintenance and monitoring in the field. Statistical methods and predictive tools make it possible to estimate failure probabilities, optimize design and reduce operational risks and costs.In addition to the technical dimension, reliability meets the requirements of regulatory bodies such as ANVISA, FDA and EMA, which require proof of safe, effective, secure and consistent performance with the intended use. Thus, more than a quality requirement, reliability engineering represents an ethical commitment to human life and the sustainability of the healthcare system.
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