📄️ Should we use CertHub's structure or build our own?
If you are setting up CertHub for a medical device organization, use CertHub's structure as your starting point. In practice, that means using Guided Setup and the libraries CertHub provides, then adapting them where your device really needs it.
📄️ How do we connect product development and test reports?
CertHub is an engineering tool. If information will be submitted to an authority or reviewed by a notified body, CertHub should be the data authority — the single controlled place where that information is maintained.
📄️ Where does this information belong?
This guide is for the questions that come up in almost every implementation:
📄️ Where does the V-model live when you develop software?
If your device includes software, the V-model is the reference for how requirements flow down to implementation and back up through verification and validation. The question most teams face is: which parts of that model belong in CertHub, and which parts stay in the engineering environment?