Medical Device Reports

                        MEDICAL DEVICE REPORTS (MDR) PROCEDURE (SOP 8-006)

The Medical Device Reports (MDR) procedure defines the decision process, including the use of internal decision trees, used to make Medical Device Reports (MDRs) to the FDA and provide instruction on how to file MDR’s. This procedure applies to all devices marketed in the United States unless excluded by FDA regulations.



Referenced Documents:
FORM 0021  MDR Decision Tree
QMSM  Quality Management System Manual
FDA Form 3417A  FDA Baseline Report Form
FDA Form 3500A  FDA Medwatch Form
21 CFR Part 803

02-25-13 GPMG’s Quality System Product Speeds ISO 13485 Certification for Manufacturers of Medical Devices

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