Starting an implementation too early
Especially in view of the increasingly strict regulatory requirements of the MDR, one of the most common mistakes is to start with the implementation without having a concrete procedure or the know-how about the individual activities and documents.
This not only creates many security gaps and a large number of SOUPs are deployed unplanned, but also an unstructured, untestable architecture and missing documentation. Closing these gaps late in the life cycle requires a lot of effort and often jeopardises the planned release date.