Many medical device manufacturers create a “software FMEA.” However, there is no uniform understanding of what a software FMEA is. This article provides clarity and tips on how to avoid the most common mistakes.
DetailsWhether risk mitigation through information is permitted regularly leads to discussions. The answer to this question is important because it determines the conformity and non-conformity of medical devices. This article provides the answer and thus resolves a “historical misunderstanding.”
DetailsThe V-model is a development process model that was originally used for government projects (e.g., armaments). To this day, it is still anchored in many people’s minds and in standards for projects in regulated environments (e.g., medical technology, banks). This leads to disputes in teams that prefer agile development processes. This article helps to resolve…
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