Human Factors and Usability Engineering Procedure
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
Human Factors Engineering (HFE) and Usability Engineering (UE) ProcedureThe Human Factors Engineering (HFE) and Usability Engineering (UE) Procedure assists medical device design teams in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses and use environments.
Human Factors and Usability Engineering Procedure - OverviewThe Human Factors Engineering (HFE) and Usability Engineering (UE) Procedure applies to human factors or usability engineering processes utilized during the development of new medical devices, with a primary focus on the user interface, where the user interface includes all points of interaction between the product and the user(s) including elements such as displays, controls, packaging, product labels, instructions for use, etc.
Human Factors and Usability Engineering Procedure - ComplianceThe Human Factors Engineering (HFE) and Usability Engineering (UE) Procedure is ISO 13485:2016, 21 CFR Part 820, ISO 14971:2012, and IEC 62366 compliant.
For more information about our Human Factors Engineering (HFE) and Usability Engineering (UE) Procedure contact us at [email protected]
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