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




January 27-29, 2015

The Park Inn
Heathrow Airport
London, England

March 11-13, 2015

Online registration

Hotel Monaco Alexandria
480 King Street
Alexandria, VA 22314
Single/double rate: $199
Rate through: February 23, 2015
Online Hotel Registration

August 26-28, 2015

Online Registration

Hotel Monaco Alexandria
480 King Street
Alexandria, VA 22314
Single/double rate: $169
Rate through: August 10, 2015

November 4-6, 2015

Online Registration

Hilton Crystal City at
Washington Reagan National Airport
2399 Jefferson Davis Highway
Arlington, VA 22202
Single/double rate $209
Rate through: October 9, 2015
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.

To register, use the online registration links above or download the registration form in pdf.


2015 FEES

AAMI members
Government employees