Federal regulators begin the pilot launch of a voluntary compliance program to allows medtech companies to voluntarily self-report regulatory violations and avoid an FDA inspection. Federal healthcare regulators are inviting certain medical device companies to self-report regulatory violations, promising that companies that cooperate will get to avoid FDA inspections. Participants must retain an outside consultant to assess manufacturing and quality assurance programs, and they must demonstrate that they have methods and resources to "define problems, analyze root causes, create appropriate corrective actions, and verify that the actions taken were effective."
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