The Association for the Advancement of Medical Instrumentation (AAMI) is offering a three-day course, Human Factors for Medical Devices, which provides a comprehensive overview to human factors as it relates to medical devices. It includes regulatory requirements of the 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. The course will be held March 10-12, 2014 at the Westin Arlington Gateway in Arlington, Va.
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.
Course faculty are drawn from an experienced group of human factors and quality system professionals; FDA’s Center for Devices and Radiological Health (CDRH) Human Factors Team; and, when possible, an invited guest speaker from FDA/Center for Drug Evaluation and Research (CDER). All course faculty have completed an instructor training program to ensure consistency and quality from session to session.
The registration fee includes PowerPoint presentations and case studies; relevant standards/and or technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch and refreshments. The cost for AAMI corporate and institutional members is $1,835; $1,935 for AAMI individual members; $2,235 for non-members; and $635 for gvernment employees.
For more details, visit: http://www.aami.org/meetings/courses/humanfactors.html