Black box testing is when test cases are derived solely from the specification of the object to be tested (product, component). White box testing, on the other hand, derives the test cases from the internal structure of the object, e.g., from its source code or software architecture. Unfortunately, many medical device manufacturers neither specify the test…
DetailsMany people ask about the liability of individuals, management, and the company. After all, it is not only the Medical Devices Regulations that impose fines and imprisonment. The question of liability also arises for development service providers. Liability in Germany: Differentiating between criminal and civil law Civil law: Parties involved In civil law, the question…
DetailsFault Tree Analysis is a procedure used to search for unknown causes of known effects (in the case of medical devices, harms or hazards). It, therefore, counts as a top-down procedure in risk analysis. Fault Tree Analysis: Notation The name Fault Tree Analysis already clarifies how it is represented graphically: As a tree. Both mind…
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