Advanced Residual Risk Analysis

About this course

This course will teach you how to perform a comprehensive residual analysis of user interaction problems as a follow-up to an HF validation test of a medical device, combination product, or software product. Frequently, an HF validation test reveals several use errors, close calls and difficulties with a given product. These interaction problems require root cause analysis followed by residual risk analysis. The instructors will teach you how to approach the residual risk analysis in a structured, reliable and data-informed manner. Additionally, they will walk through the nuances of residual risk analysis that will help you write compelling residual risk commentaries. In turn, this should you guide medical products through the end-stage of the HFE process, including preparation of compelling regulatory submissions.

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 residual risk analysis.

Meet the instructors

The instructors are highly experienced, having led residual risk efforts in their previous industry roles and now on behalf of their Emergo by UL projects. Accordingly, you will learn how to perform residual risk analyses with high confidence and assurance that your approach matches regulators’ expectations.

Merrick Kossack, research director

For over 25 years, Merrick has helped companies develop processes and strategies to address their human factors engineering needs, particularly for complex and high-risk systems. His areas of expertise include integrating human factors engineering into established design and development processes, conducting complex usability studies, and advising on human factors strategy to satisfy regulatory needs. He received an M.S. degree in Human-Machine Systems Research from the Georgia Institute of Technology and a B.S. degree in Industrial Engineering from the University of Illinois. Merrick is a contributing author to Applied Human Factors in Medical Device Design (2019) and has delivered numerous presentations on the subject. He is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) Human Factors Engineering subcommittee as well as IEC TC 62/SC 62A/JWG 4, both responsible for the creation of human-factors-related standards and guidance. He is also a member of the AAMI faculty staff teaching their Human Factors for Medical Devices course. In 2020, Merrick was inducted into UL’s William Henry Merrill Society as a Distinguished Member of Technical Staff.

Jenny Collinson, research director

Jenny Collinson is a research director with Emergo by UL’s Human Factors Research and Design team, joined in 2021. Her deep medical device industry experience includes more than 15 years in both product development and human factors engineering roles. Collinson has experience in building HFE processes, integrating them into research and development activities, and creating robust human factors engineering strategies, validation plans and documentation that meet the requirements of regulatory bodies. She completed a master’s degree in Applied Ergonomics from the University of Nottingham.