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 ...
01/19/2018
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? ...
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. ...
10/30/2017
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, ...
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