About this course
Frequently, usability testing reveals several use errors, close calls and interactive difficulties with a given product. Such user interaction problems warrant root cause analysis en route to determining solutions (e.g., revise the product, add a warning, revise the instructions, provide better training). A strong root cause analysis links directly to ensuring that finished medical products are safe, effective and satisfying. It also links directly to residual risk analysis that determines if a product design should be revised or is acceptable “as is.” You will learn from highly experienced, root cause analysts how to approach the analysis in a structured, reliable, and data-informed manner. The course will also provide the opportunity for you to practice root cause analysis and receive feedback. The instructors will also walk through numerous examples of taking a root cause from mediocre to excellent.
Within a 1-month period following the online course, you may schedule a 1-hour, complimentary consultation with the instructors to ask any specific and company-confidential questions about performing root cause analysis.
Number of courses
Meet the instructors
The instructors, who are co-authors of “Medical Device Use Error – Root Cause Analysis,” will walk through a structured process to help you perform root cause analyses with high confidence and assurance that your approach matches regulators’ expectations.
Andrea Dwyer, associate research director
Andrea Dwyer has been with Emergo by UL’s Human Factors Research & Design (HFR&D) team since 2010. A board-certified human factors professional, Andrea leads and oversees research activities required to meet regulators’ expectations for applying human factors engineering (HFE) during medical device development. She composes HFE project plans and helps medical device and pharmaceutical manufacturers develop key HFE documents for their design history files, including authoritative HFE reports and comprehensive use-related risk analyses. She frequently conducts workshops, speaks at industry events, and advises clients on how to implement HFE in the medical device development process. Andrea is co-author of Medical Device Use Error –Root Cause Analysis. She holds a B.S. in Human Factors and an M.S. in Engineering Management, both from Tufts University.
Erin Davis, associate research director
Erin Davis has been with Emergo by UL’s Human Factors Research & Design (HFR&D) team since 2012. Erin helps our clients learn about and apply HFE effectively by managing OPUS, our HFE software platform, and by teaching workshops on various HFE topics. She has experience delivering HFE services to the medical device, pharmaceutical, scientific instrument, and laboratory equipment industries. A board-certified human factors professional, Erin advises on regulatory expectations, leads and oversees research activities such as user research and usability testing, and performs key HFE analysis tasks including use-related risk analyses, known problems analysis, and residual risk analysis. Erin is co-author of two books: Medical Device Use Error – Root Cause Analysis and User Interface Requirements for Medical Devices. She has also served as President of the Human Factors and Ergonomics Society’s New England Chapter. She holds a B.S. in Biomedical Engineering from Marquette University and an M.S. in Human Factors from Tufts University.
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.
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