See IEC 62304:2006 (https://www.iso.org/standard/38421.html https://www.iso.org/standard/38421.html) and the related standards which govern the formal processes

See IEC 62304:2006 (https://www.iso.org/standard/38421.html https://www.iso.org/standard/38421.html) and the related standards which govern the formal processes which medical device software must meet for FDA and CE approval (as well as other national standards). The whole process from requirements, specifications, high and low level design, implementation, validation and verification and the rest of the lifecycle requires stringent oversight, including documentation and signoffs. The signatures on those documents have legal meaning and accountability for the engineers who did the analysis and review at each stage.