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The Association for the Advancement of Medical Instrumentation (AAMI) will offer the Human Factors for Medical Devices Training Program August 26-28, 2015, in Alexandria, Va. This course will provide an introduction to human factors, regulatory requirements of FDA as they relate to human factors, and the role of human factors in design controls. It also provides a basic foundation for application of human factors, with discussions on user models and task analysis; anatomy of use errors; and task analysis as a basis for planning human factors efforts. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device.
A basic foundation for applying human factors will be set, with discussions 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. Relevant human factors standards are discussed as well as human factors in the post-market arena. There are hands-on exercises as well as real-life case studies illustrating the application of human factors to medical devices.
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 trainers are:
- Robert North, PhD, chief scientist, Human Centered Strategies
- Evan Edwards, MS, vice president of product development, kaléo, Inc.
- Edmond W. Israelski, PhD, CHFP, director of human factors, AbbVie
- Ronald D. Kaye, MA, leader of the human factors pre-market evaluation team, Office of Device Evaluation, Center for Devices and Radiological Health, FDA
- Irene Z. Chan, PharmD, BCPS, Center for Devices and Radiological Health, FDA
Registration fees are $2135 for AAMI members, $2435 for non-members, and $735 for government employees. To register, CLICK HERE.