We often give little thought to terms we use frequently. Therefore, it's helpful to clarify terminology and maintain a glossary within the project. This should also include the terminology used to describe patient-related connections. We ...
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. ...
08/16/2019
Finite state machines, also known as state machines or state diagrams, define the possible states of a system. Documentation can be presented in tabular or graphical form. Since the number of table rows increases significantly with the number of states, ...
06/25/2019
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 ...
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