Human Factors of Medical Devices

This course focuses on industry needs and expectations for human factors engineers in the medical device application area. This course is to cover human factors topics, learn human factors assessment techniques, and apply these knowledge and methods to fulfil regulatory requirements (focusing on HE75 and FDA human factors guidance.

IE59000

Credit Hours:

3

Learning Objective:

  1. Introduce the human factors applications in medical devices
  2. Review the state-of-the-art Human Factors Engineering techniques
  3. Understand and identify factors that impact patient and provider safety
  4. Apply course knowledge to fulfill federal and international human factors requirements, e.g. HE75

Description:

This course focuses on industry needs and expectations for human factors engineers in the medical device application area. This course is to cover human factors topics, learn human factors assessment techniques, and apply these knowledge and methods to fulfil regulatory requirements (focusing on HE75 and FDA human factors guidance.

Topics Covered:

We will first provide an overview of core human factors background, learn usability and assessment methodologies, and understand the human factors requirements for medical device evaluation.

Prerequisites:

Previous courses in human factors helpful but not required

Applied / Theory:

50 / 50

Textbooks:

All materials provided

Computer Requirements:

ProEd Minimum Requirements:

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