Medical Device Requirements: A View from Canada: Symposium on “Global Challenges in Human Factors and Medical Systems” Session 1: “Medical Device Design and Labelling Requirements for the Global Market”

Abstract

This paper provides an overview of the Canadian Medical Device Regulations and focuses on those requirements that may impact on human factors and ergonomic issues. Additionally, the paper provides examples of specific incidents with medical devices that occurred in Canada where ergonomic and human factor issues were directly responsible for the problem.