White Paper: Hypothetical Problem Situations Involving Medical Device Reporting

You have just started as Complaint Coordinator at a large medical device company.You inherit some open complaint files. On your first day, you review the files and find that one of the complaints appears to be MDR reportable and the report is at least 30 days overdue. You notice, however, that this type of complaint is not reportable under the company's internal MDR reporting guideline for this product. It turns out that the company's internal guideline does not properly conform to the requirements of FDA's MDR regulation. Upon investigation, you learn that there may be as many as 300 to 400 similar complaints in the past three years that the company did not report to FDA, because of the inaccurate MDR reporting guideline.
What should you do?

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