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OPUS™ - Human Factors Document Library and Report Templates

Access pivotal HFE documents that align with medical product regulatory requirements. Access documents on our HFE software platform, OPUS™ – Optimal Product Usability Suite™.

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Human factors reports, templates and more

The Document Libraries contain dozens of HFE documents that help you efficiently produce high-quality HFE documentation, while also ensuring that your work aligns with the latest medical device, combination product and in-vitro diagnostic regulatory practices.

Use an OPUS document as a starting point or use it to identify opportunities to enhance documentation that you have already developed.


Our template library includes documents that align with FDA, IEC62366, MDR, and MHRA requirements. From formative protocols to use-related risk analysis tables to HFE reports, our templates help you produce high-quality HFE documentation efficiently.

User profiles

Understanding users and designing to meet their unique characteristics is an important part of the HFE process. Our user profile library provides easy access to detailed profiles for lay users and healthcare professionals. Each profile describes details such as demographic characteristics, education/certification, skills, potential impairments, performance shaping factors, and learning styles.

Use environment descriptions

Understanding the environments in which a product is used and designing a product to suit that environment is also essential. Our use environment descriptions library provides easy access to detailed descriptions for clinical and non-clinical environments. Each description presents details such as the environment’s architecture, equipment, furniture, supplies, lighting, noise, climate, people and potential distractions.


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Emergo by UL’s new cloud-based human factors engineering (HFE) platform, Optimal Product Usability Suite (OPUS™), leverages training, tools, templates and regulatory guidance to help you stay ahead in your HFE activities.

Sign up for courses on our HFE software platform, OPUS.

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