Human Factors for Medical Devices
Understand critical human factors processes to consider when designing a medical device, including how they affect its safety and which steps to take to mitigate risks
About the course
Medical device manufacturers with robust human factors processes are leading the market, delivering better clinical outcomes and better quality. Attend AAMI’s three-day Human Factors for Medical Devices training to understand critical human factors processes to consider when designing a medical device. Hear directly from FDA representatives from CDRH and CDER about the expectations for device usability, how best to conduct human factors evaluation and testing, the premarket review process, and how strong human factors processes should be a part of the design and development of medical devices.
What to expect
The course will set a foundation for applying human factors with discussion on user models and task analysis; anatomy of use errors; and how task analysis forms the basis for planning human factors efforts. Course content will also include a review of human
factors methodologies—contextual inquiry, heuristic evaluations, formative studies, and summative studies. Explore relevant human factors standards, as well as human factors in the postmarket arena. There will be hands-on exercises and real-life case studies illustrating the application of human factors to medical devices.
Who should attend?
This course is designed for quality and design engineers; research and development managers; risk managers; personnel from marketing, regulatory affairs, quality assurance, clinical/medical affairs, and customer service; and government regulators who
are new to the application of human factors to medical devices. AAMI recommends this course for professionals who already have a basic understanding of the framework of quality management systems, particularly design control, risk management, and
CAPA activities, but need more in-depth information about the concepts, science, processes, methodologies, and practical applications of human factors. It is recommended that human factors personnel who are new to the medical device industry have
working knowledge of the Quality System regulation and design controls.
The fee includes a copy of ANSI/AAMI/IEC 62366-1:2015 (a value of $243), FDA guidance documents, industry studies and references, and an eNotebook of the presentations with easy note-taking capability.
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Virtual Training Information
Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email firstname.lastname@example.org.