The use of model-based tools for requirements management is intended to make our lives easier and our work more efficient. However, these tools are often used merely as a replacement for Word. The requirements are entered into the tool, and then a ...
07/31/2017
Sometimes things happen whose consequences only become truly apparent years later. Such a thing happened on May 25, 2017. EU Regulation 2017/745 entered into force. The MDR replaces the MDD (93/42/EEC) and the AIMD (90/385/EEC). ...
04/09/2017
Over 10 years in medical technology. What have I learned here, and what recommendations can I offer? Goran Madzar approached me with this question and asked if I'd be interested in writing a guest blog. I'm happy to help. ...
03/22/2017
I often read in specifications that the new system should behave like the old one. But how does the old one behave? If you don't have a corresponding specification, you're basically just guessing. Often ...
01/14/2017
The word "documentation" often makes people shy away. Creating, reading, or searching for documentation – usually not a very enjoyable task. Yet documentation is necessary and important. The goal is to minimize the effort. ...
11/05/2016
Things were better in the old days. Who hasn't heard this saying? It's often used when ever more processes and regulations rob us of the joy of work. But is it even possible to work today without getting lost in a jungle of processes? ...
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