Regulators are incredibly difficult to work with. They are bureaucratic and look at issues one-dimensionally & legalistically. Has anyone ever had to deal with the government with anything? Difficult right? It's even harder when they fail to grasp the issues or they fail to pay attention to the actual issues being discussed.
Imagine then the issues with dealing with a regulator, that see's one dimensionally and is trying to understand the very complex subject matter of clinical trials, results and outcomes.
It is a difficult process and a real challenge for any med-tech company to navigate successfully.
CE Mark Odds, page-144
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