usability engineering in medical devices

| December 10, 2020

IEC 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. Formative evaluations are a major part of the design and development process. Regulatory requirements for safe and effective medical devices are ever-changing, however the majority of new and emerging frameworks mandate stronger and deeper considerations of human factors/usability engineering to ensure patient safety and clinical performance prior to market access and beyond. normal use. Medical devices to be safe and easy to handle is the requirement across all the … Medical devices to be safe and easy to handle is the requirement across all the regulations. Meanwhile, in the EU, there is an on-going effort to harmonise the most recent usability engineering standard, IEC 62366-1:20… Comprehensive service offerings at every point in the product life cycle. Describe how data will be collected during the test. Medical devices must meet certain requirements to be marketed in Europe and the United States. User interface specifications can be derived from the use specifications, user interface characteristics, use errors identified within the risk management process. The International Electrotechnical Commission (IEC) has published the first edition of the usability engineering standard “Application of usability engineering to medical devices”. Having said that, IEC 62366-1:2015 is the standard recognized by the European Union, USFDA and the other major countries where the medical device regulations are stringent and difficult to comply. IEC 62366-1, 1.1 Edition, June 2020 - Medical devices – Part 1: Application of usability engineering to medical devices This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. User interface specifications are the testable requirements relevant to the user interface. The Usability Engineering PROCESS addresses USER interactions with the MEDICAL DEVICE mostly during the following processes related to use of the medical device. Human Factors Engineering and Usability Testing Services Market: Distribution by … Historically, manufacturers of active medical devices, including software should be familiar with the application of usability engineering during product development. Medical device regulations: The UK Government’s forthcoming regulations on medical device approvals will almost certainly have usability requirements that are identical to those inherent in the EU MDR. The formative evaluation plan should address the objective, evaluation method and the type of user interface that is being evaluated and the criteria of acceptability. Part 2: Guidance on the application of usability engineering to medical devices • To be more “usable”, easier to understand than original 62366 • Contains the “what” requirements in Part 1, the “how” is in 62366-2 • Closer ties to risk management, EN ISO 14971 • Closer to FDA guidance 35 . 2. Please refer to this standard for the definition of other terms. General requirements for basic safety and essential performance. Usability may be evaluated by understanding the characteristic of the USER INTERFACE that facilitates use and thereby establishes EFFECTIVENESS, EFFICIENCY and USER satisfaction in the intended USE ENVIRONMENT. Similar to the formative evaluations, summative evaluations can be performed in a single or multiple iterations. There could be a single plan capturing the evaluations of all the user interface specifications or there could be multiple plans made at the each stage of the design and development of the medical device. 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