There are 11 document types in the basic V&V Documentation model as per “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”, Table 3, May 11, 2005: LOC (Level of Concern: Min, Mod, Maj) SW Description Hazard / Risk Analysis (ISO 14971 / ICH Q9 = recommended       model; ultimately Read more about V & V Documentation Model – 11 Documents[…]