Version changes in medical software: proposing minimal requirements for release notes and a version number convention - an operators' point of view.

Medical software - like any other software - is susceptible to errors. To avoid false system behaviour or attenuate its consequences, system operators need to know about changes in the software. The goal of this proposal is to define terms and minimum requirements regarding documentation for a version change from the operator's point of view, especially in the domain of medical software or software as a medical device (SaMD). The results are a classification of version changes (Upgrade: breaks support for a rollback to a prior version, Major Update: either substantial configuration or user education needed, Minor Update: minor configuration or user information needed, Patch: collection of (small) changes that require neither configuration nor user information.). Additionally, minimal requirements for release notes are determined and a document structure recommended.