Relevant Articles

Post-Market Audits

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!

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Post Test Inquiry: What if there are no use errors?

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...

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