ISO 13485:2016 requires a risk-based assessment of your processes in the quality management system (QMS). Many companies ask themselves whether only production processes should be considered, or whether all processes should be considered. Furthermore, the question often arises, ...
10/13/2015
For risk management, the approach in "Systems in Medical Technology – Setting Reasonable Limits" is a useful aid. However, the system boundary itself is not enough; we must look beyond it. The first question that arises ...
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