Application of risk management to medical devices The third edition of ISO 14971 was published in December 2019. This article summarizes the standard and discusses the changes in the standard. Why a new edition? According to ISO, ...
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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