The MDR requires medical device manufacturers to conduct Post-Market Surveillance (PMS) and thus collect PMS data. This article is intended to help clarify the regulatory requirements manufacturers must consider when collecting these PMS data. Notably, it is intended to highlight whether manufacturers need to consult an ethics committee in Europe if the data arise from…
DetailsBoth IEC 62304 and the FDA require integration tests. 1. What are integration tests? Integration tests verify whether software components that use interfaces of other components, i. e. call its methods, properly handle their returns (return values, exceptions). 2. Why are integration tests necessary? a) Improve the quality of the software Integration tests, like all…
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