Or: how to quickly turn an idea into a prototype. I don't know about you, but I often have ideas for useful gadgets that can make my everyday life easier. Recently, this was ...

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05/08/2020

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, ...

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In one of my recent projects, we were able to experience a scary-but-beautiful lesson on the topic of "separating problem and solution space." I would like to share this experience with you: For controlling a motor and two brakes, ...

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01/29/2019

SW metrics from a QMS perspective Why should software quality metrics be used in the product lifecycle? A software metric maps a software unit into a numerical value. The numerical value represents a measure of the internal quality of software. Software code metrics are ...

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The legislator imposes a multitude of requirements on all electrical devices and systems, which must be met for successful CE conformity. An approval process therefore includes at least the three major chapters "electrical safety", "electromagnetic compatibility (EMC)" and "restriction of ...

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The software development plan Part: What is a software development plan Part: What does a software development plan look like What does a software development plan look like, according to the requirements of 62304 Now that we know what a software development plan is, the question naturally arises, what ...

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