Usability documentation of a diagnostic software for IEC 62366-1 und FDA

Analysis of user groups, use context and technical environment affected by new functionalities. Technical derivation of use errors and potential misuse. Adapting product requirements and effort estimations to planned use risk mitigations. Documentation of all use risk-related activities according to IEC 62366-1 International Standard – Medical Devices – Application of usability engineering to medical devices and FDA – Applying Human Factors and Usability Engineering to Medical Devices