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.

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

2015 DatesLocationPhone & RatesOnline Registration
August 26-28
Hotel Monaco Alexandria
480 King Street
Alexandria, VA 22314
Single/double rate: $169
Rate through: 8/10/15

Online registration

November 4-6
Hilton Crystal City at
Washington Reagan National Airport
2399 Jefferson Davis Highway
Arlington, VA 22202
Single/double rate $209
Rate through: 10/09/15

Online registration

NOTE: Reservation requests should be made as soon as possible, but no later than the 'rate through' date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline.

Additional Info

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

View a detailed outline of the course.


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.

Fees & Registration

Fees include:  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 members:  $2135
  • Nonmembers:  $2435
  • Government employees:  $735

Registration options include: 

  • Online at the online registration links in the hotel chart
  • Phone  +1-800-373-3174, to order with credit card
  • Fax the registration form (PDF) to +1-240-396-5781