Image: Flowchart

MDO Article: “How To Know You’ve Passed Validation Testing (And What To Do If You Haven’t)”

Understanding the ramifications of less-than-perfect validation testing results can be complex. In his recent article for Med Device Online, Peter Sneeringer presents 6 questions to help companies decide if errors seen during testing indicate a likelihood that the FDA will reject their submission.

The article is an adaptation of a presentation given at the 2015 HFES Symposium on Human Factors and Ergonomics in Health Care.