Registration 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. 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.
Program At-A-Glance
- FDA Perspective
- Identifying User Requirements
- User Requirements Analysis for Device Design Inputs
- Human Factors User Research & Design Tools
- Human Factors Testing & Evaluation Methods
- User Related Risk Assessment Methods
- Lessons Learned from the Application of Human Factors to Real Medical Device Design
- Overview of Human Factors Medical Device Standards
- Human Factors Life-Cycle Planning
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.
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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.
Fees and Registration
Fee includes participant notebook of course
materials and case studies; pertinent FDA documents and
additional references; and continental
breakfast, lunch, and refreshments.
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