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, ...
10/02/2017
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, ...
04/09/2017
Over 10 years in medical technology. What have I learned here, and what recommendations can I offer? Goran Madzar approached me with this question and asked if I'd be interested in writing a guest blog. I'm happy to help. ...
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 ...
07/05/2015
Do you have expertise in medical technology and are you an absolute expert in your field? Then share your knowledge with others! If you have an interesting topic but perhaps shy away from the effort of running your own blog, ...
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