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A single example of noncompliance, if it is egregious enough, may cause the Food and Drug Administration to terminate your ability to market a device in the United States.
Indeed, compliance is one of the major sources of overhead in the medical device industry – and in several other regulation-driven sectors.
In the long run, when it is discovered – and it will be – the consequences are disastrous.
Let’s consider major noncompliance cases that rocked the United States
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