Failure Mode and Effects Analysis (FMEA) is a risk management method. ISO 14971 states: "Failure Mode and Effects Analysis (FMEA) and the analysis of failure modes and effects ...
04/22/2019
Have you ever inherited anything? An inheritance or a legacy can certainly be a positive thing. Another word, however, is more thought-provoking: legacy! The term legacy, unlike legacy, is considerably less value-laden and indicates..., ...
04/08/2019
At some point in the lifecycle process, a change request arises. This necessitates a review of previous activities. What is the best way to handle change requests for software or a system? Because the goal ...
03/15/2019
Use cases can be documented graphically in a use case diagram. Use case diagrams are easy to use and are well-received by project stakeholders. This article is intended to help you model use case diagrams correctly and effectively. ...
12/12/2018
Anyone developing medical devices inevitably has to deal with risk management. However, many companies struggle with this topic. And system architecture is still in its infancy for many companies. Yet these two disciplines are precisely what is needed. ...
11/12/2018
Sequence diagrams are used to dynamically model communication processes and interactions between system components.¹ The temporal progression takes on particular importance in this form of representation. This article is intended to help you model sequence diagrams correctly and meaningfully. ...
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