Module 14 2022

24/03/2022

What is the Human Factors and Usability Engineering process? The Human Factors Engineering and Usability Engineering processes vary dependent on the regulation compliance is required for. Very subtly. The differences are small but all have the same outcome: mitigation and evidence to support a

rationale of use safety, to ensure the clinical benefit of the drug device combination product outweighs the inherent risks of use. All standards link to ISO 14971 (2012) and not the 2019 version since it has recently been revised. All processes follow the same route – INPUTS, PROCESS and OUTPUTS.

Source: Human Factors and Usability Engineering – Guidance for medical devices including drug device combination products . The MHRA Human Factors and Usability method.

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Human Factors and usability testing during development

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What is the Human Factors and Usability Engineering process? What documentation should be included in a Human Factors and Usability Engineering process?  Use Specification – where the intended users, use environments and use scenarios are defined.  Task Analysis – where the intended tasks and use scenarios are determined.  Usability/Human Factors Risk Assessment – where task-based risks are evaluated and use- based risk determined.  User Interfaces / Validation Test Plan – where the user interfaces are defined and their routes for verification and validation are determined.  Formative Usability/Human Factors Studies – where design concepts, user interfaces, software, hardware and the final design of the device are tested with intended users to verify the design.  Summative Usability/Human Factors Test – where production-level devices are tested with intended users, in the intended use environment, under typical use conditions to validate the device design meets the users needs.  Usability/Human Factors Engineering File – where all the usability and human factors effort is contained.

The Organisation for Professionals in Regulatory Affairs

Human Factors and usability testing during development

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