> What about showcasing devices that pretended to work but then shipping the tests to be run in normal labs? They didn't even have any basic systems validation

> What about showcasing devices that pretended to work but then shipping the tests to be run in normal labs? They didn't even have any basic systems validation / quality management documentation, which is how they racked up their first FDA inspection violations. This really should have been obvious to anyone doing due diligence in a regulated space (devices, pharma, etc.).