We have already described the basics and the necessity of insulation diagrams for documenting electrical safety according to 60601-1 in several articles: Electrical safety in medical technology according to 60601-1 Insulation diagrams in medical technology Insulation diagrams according to 60601-1 Part 1: Basic concepts ...

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„"My client/product manager doesn't know what they want!" Often, customer requirements in development projects are unclear, and there's no suitable requirements specification. However, carrying out a development project without understanding the customer requirements can lead to project failure. ...

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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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Are you still planning, or are you already developing? There's a lot of discussion about why a software development plan is even necessary. Almost no one would think of starting a major project without a plan. Who builds a house without a plan? ...

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12/11/2017

In a recent project, I worked with the software developer last week to create a software release plan. The release plan serves to visualize the sequence in which software is developed and when it will reach a specific level of maturity. ...

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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... ...

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