Raffaele Caliri and Jordan Pate have recently updated our 62366-1 Assessment Checklist to align with the 2020 amendment. This version of the standard has been pared down a bit and looks a lot different than the familiar 2008 version used for so many years. This checklist can be helpful for internal audits, supplier audits, training, and other quality improvement activities. However, we recommend that the checklist not be used verbatim, but more as a tool to review your quality management procedures. Your usability procedures should be written to the methods and tasks that your organization uses.
Download the checklist here: SoftwareCPR-62366-1-2015-A1-2020-checklist-r1
Keep in mind that 62366-1 compliance may not meet all of the US FDA expectations for SaMD and/or medical devices. We recommend that you also read the FDA Human Factors guidance … download it here: 2016-02-Applying Human Factors and Usability Engineering to Medical Devices-Draft Guidance
SoftwareCPR can assist with assessing your usability engineering process and help to align with the software development lifecycle (SDLC).
