Usability Testing

Overview

Ascertaining the safety of medical devices obviously includes the human factor – the people who are using the device must be able to do so safely and effectively. UL's usability testing services are aimed at achieving compliance with regulatory requirements, reducing medical device use error, helping manufacturers create user-friendly devices, and reducing training costs.

Definition

UL provides full life-cycle usability testing services to meet medical device manufacturers' regulatory, standards certifications and marketing requirements.

Benefits

Working with UL enables our customers to access a comprehensive service package through one expert provider. Our worldwide footprint provides both extensive global knowledge and local expertise. UL customers have access to knowledge experts who fully understand their targeted markets.

We work with our customers to determine the appropriate usability testing required and prepare a project plan tailored to current and future product launch needs.

We provide independent third-party testing of medical devices, products, and design processes along with actionable business intelligence. This includes integrated assessments to ISO 62366 and IEC 60601:2005, the standards recognized by most global regulatory agencies.

UL human factors engineering (HFE) experts facilitate formative and summative usability testing and analysis to help meet U.S. FDA and other regulatory requirements for approval. We test product performance by objective means, such as determining task time, task completion rates, errors, and use-related risk analysis. Working with a panel of representative end users, who perform a cross section of tasks, enables us to highlight product strengths and shortcomings. Products can also be benchmarked according to established usability metrics.

We have supported the writing of the guidance documents and develop test plans to support specific regulatory needs along with any development needs for a competitive advantage.

We offer user interface design support, including assessment of software and hardware user interfaces, as well as reviews of the accompanying documents such as user manuals and quick-reference guides.

We further support our customers by offering critiques of evolving design solutions and training, including technical talks and workshops.


DELIVERABLES


PRODUCTS THIS SERVICE APPLIES TO

Medical devices

APPLICABLE STANDARDS

ANSI/AAMI HE75:2009 Human factors engineering – design of medical devices. Provides detailed guidance on how to perform specific human factor analyses and offers a wealth of design principles
ISO/IEC 60601-1-6 General requirements for basic safety and essential performance – Collateral standard: Usability
ISO/IEC 62366:2007 Medical devices – application of usability engineering to medical devices

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