Documentation Template for the Usability Engineering Process for Medical Devices

摘要

Introduction: Medical device regulatory processes are currently based on technical (ISO IEC 62366:2015) and regulatory standards (IEC ISO 60601-1-6:2015), which provide an international standard to be applied in evaluating devices and their documentation. However, the lack of standardization in the usability engineering processes used by the manufacturers, and the absence of pre-established metrics for such processes are constant problems in the medical device universe, particularly hindering the evaluation processes. It was verified that the current norms are insufficient to guarantee good usability engineering processes, even with the existence of good usability practices in the literature. Objective: This paper presents an analysis of the requirements contained in current standards and proposes a documentation model for usability engineering of medical devices, from the presentation of some techniques that are used in the process of device development. Method: This work is based on literature reviews to identify the state of the art in usability engineering; analysis of current standards, to verify what the regulatory requirements are, and how to comply with them; comparative studies with existing documentation to identify strengths and weaknesses in documentation processes; and elaboration of documentation prototypes. Results: From these results, it was possible to prepare a template document with all the points required by the current norms. Appropriate techniques were also listed for the accomplishment of some stages of the process, creating greater rigidity in the definition of the parameters of the documentation.