Over the past two years, we are seeing a number of companies be audited by FDA regarding adherence to their own Design Controls procedures. In particular, validation is the topic, or actually, failure to validate!

Perhaps the most important usability study begins when a medical device has been approved for market and purchased by customers. Real world use problems and usability assessment isn't readily obtainable unless manufacturers systematically obtain this data through post...

Post test inquiry is perhaps the most important feature in human factors validation testing.  We want to know everything we can about observed failures and difficulties that occur in the study.  We follow up on these instances by asking specific questions about the...