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, 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.

Program At-A-Glance

  • Introduction
  • Course Overview
  • FDA/CDRH Pre-Market Review Perspective
  • Preliminary Analyses for Pre-Market Approval
  • Formative Evaluation and Design Modification
  • Human Factors Validation Testing
  • HF/Usability Report
  • Case Study 1: Planning and Conducting Human Factors for Auto-Injector Drug Delivery Device
  • Overview of Human Factors Medical Device Standards
  • Application of Human Factors in Medical Device Design
  • Validation Exercise
  • Link to detailed agenda

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

November 3-5, 2014 The Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203
Single/double rate: $215
Rate through Oct. 10, 2014
NOTE: Reservation requests should be made as soon as possible. Rooms are assigned on a first-come, first-served basis and may sell out.


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.

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.

AAMI corporate and institutional members
AAMI individual members
Government employees