For certification according to IEC EN 60601-1, TÜV will generally require an insulation diagram. However, searching for the term "insulation diagram" in the basic standard 60601-1 yields no results. This article will describe what... ...
10/15/2017
I was currently working on a firmware project that I only joined after most of the code had already been written. Since I hadn't participated in the development of the firmware modules implemented up to that point, and therefore ...
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, ...
08/27/2017
The use of model-based tools for requirements management is intended to make our lives easier and our work more efficient. However, these tools are often used merely as a replacement for Word. The requirements are entered into the tool, and then a ...
07/31/2017
Sometimes things happen whose consequences only become truly apparent years later. Such a thing happened on May 25, 2017. EU Regulation 2017/745 entered into force. The MDR replaces the MDD (93/42/EEC) and the AIMD (90/385/EEC). ...
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. ...
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