Human Factors for Medical Devices
This 3 day course offers participants a comprehensive overview to human factors as it relates to medical devices. It includes regulatory requirements of FDA as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device.
Program At-A-Glance |
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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.
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.
Dates & Hotels
| DATE | LOCATION | PHONE & RATES |
| June 17-19, 2013 | Renaissance Arlington Capital View Hotel 2800 South Potomac Avenue Arlington, VA 22202 Website |
703-413-1300 $209 single/double Rate though: 5/19/2013 |
| October 14-16, 2013 | The Westin Arlington Gateway 801 North Glebe Road Arlington, VA 22203 Website |
703-717-6200 $209 single/double Rate through: 9/15/2013 |
| December 2-4, 2013 | The Westin Arlington Gateway 801 North Glebe Road Arlington, VA 22203 Website |
703-717-6200 $209 single/double Rate through: 11/8/2013 |
| NOTE: Reservation requests should be made as soon as possible. Rooms are assigned on a first-come, first-served basis and may sell out. | ||
Faculty
Course faculty are drawn from an experienced group of quality system professionals. All course faculty have completed an instructor training program to ensure consistency and quality from session to session.
Fee and 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.
| REGISTRATION TYPE | FEES |
| AAMI corporate and institutional members | $1835 |
| AAMI individual members | $1935 |
| Nonmembers | $2235 |
| Government employees | $635 |