Abstract

[This abstract is based on the authors' abstract.]The requirement to validate software tools that are used to develop, verify, or validate medical device designs is a frequently overlooked aspect of the FDA's quality system regulation for the medical devices industry. While validating software tools used to develop medical devices may not seem as critical as validating the software in the medical device itself, it is still an important activity that should not be overlooked. The level of effort that should be expended in the validation is driven by the level of risk inherent in the medical device, the possible consequences if the tool failed, and the degree to which the organization relies on the tool to ensure the quality of the design. This article seeks to raise awareness of the regulatory requirements, and discusses how to create a tools validation program that will satisfy the regulations without proving too onerous.