Medical device software. Software life-cycle processes Ingestion-build-67170 It contains no test methods

It contains no test methods

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Medical device software. Software life-cycle processes Ingestion-build-67170 It contains no test methodsWhat is this standard about? It deals with medical device software. The amendment adds requirements for legacy software which will help manufacturers demonstrate compliance with the relevant European Directives. Who is this standard for? The standard is relevant to manufacturers of: Medical electrical equipment Medical devices incorporating software Software that is itself a medical device Why should you use this standard? The amended standard applies