March 9, 2022
CONCORD, Mass., March 9, 2022 -- Emergo by UL, a global medical device and healthcare technology consultancy, has launched a web-based platform, Optimal Product Usability Suite™ (OPUS). This software as a service (SaaS) offering provides medical device and technology manufacturers with efficient access to human factors engineering (HFE) capabilities to support regulatory and commercial efforts.
Incorporating HFE processes into medical device development, including in vitro diagnostic devices and drug-device combination products, helps manufacturers meet regulatory requirements in key global markets. HFE processes can also enhance device safety and effectiveness by reducing the risk of use errors and improving device usability and appeal. However, establishing robust HFE expertise in-house can prove time-consuming and costly for many manufacturers. OPUS can accelerate the process and reduce the cost.
Developed by the HFE experts on Emergo by UL's Human Factors Research and Design team, OPUS™ features streamlined access to training, templates and tools that facilitate the effective application of HFE. Key features include:
- HFE training courses and certification, with customizable timeline and learning pathway options
- Project planning tools including progress trackers and deliverable lists to manage a company's efforts to meet regulatory expectations
- Guided HFE workflows
- Document libraries and template bundles to ensure robust HFE documentation
- Productivity tools to support analysis, design, evaluation and validation efforts
Medical device and technology manufacturers, regulatory affairs advisors and educators, among others, may register on OPUS™ at the complimentary Core Level, which includes access to guided HFE process and productivity tools. Or, they can upgrade to the Premium Level, which gives them access to a large collection of training modules, HFE document libraries and additional resources.
"Medical technology manufacturers recognize the need to apply human factors engineering intensively during product development, but demand for HFE expertise can often outpace the capacity of internal teams," says Michael Wiklund, general manager and director at Emergo by UL's Human Factors Research and Design practice. "With OPUS, we're providing a digital solution that enables medical technology companies to build internal HFE capabilities that ultimately will help to improve patient outcomes in an efficient and scalable way."
About Emergo by UL
EMERGO by UL is a leading human factors engineering and regulatory consulting firm. Our solutions help you bring regulation-compliant, safe, effective and satisfying products to market. With a presence on six continents, we can provide real-time service and on-the-ground expertise. Discover more about Emergo by UL's Human Factors Research and Design.
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