If you are certified according to DIN EN ISO 13485, or if that is your goal, you have probably already come across tool validation. Perhaps this article can help you and shed some light on the subject. Why do you need ...
01/07/2021
Does RoHS mean anything to you? The abbreviation stands for "Restriction of Hazardous Substances," with the official German name "Restriction of the use of certain hazardous substances in electrical and electronic equipment" [3]. By now, I think every electronics developer is familiar with the term "RoHS." But ...
10/22/2019
The safety concept is one of the important concept documents we create during product development. It describes why a device is safe and how safety is ensured in the event of a malfunction. Various aspects are considered, such as mechanical safety. ...
09/10/2019
ⓘ This event has already taken place. The VDI Systems Engineering working group will meet again in Erlangen on September 26, 2019, starting at 5:30 p.m. This meeting will focus on arc42, a template for development, documentation, and communication. ...
04/22/2018
„"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. ...
01/26/2018
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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