Quality Suite Checklists™ - Medical Devices
The starting point are the national regulations of the United States and the European Union.
|Medical Device Reporting||21 CFR 803||MED.10|
|Good Manufacturing Practices for Medical Devices||21 CFR 820||MED.20|
Medical Device Reporting
The medical device reporting (MDR) requirements of 21 CFR 803 apply to manufacturers, importers, distributers, and device user facilities in the United States. Such facilities are required to report adverse device-related events to the Food and Drug Administration (FDA) or the device manufacturer, and occasionally to both. These requirements are supplemental to the quality system requirements of 21 CFR 820 in Quality Suite MEDICAL DEVICES Good Manufacturing Practices for Medical Devices checklist.
Good Manufacturing Practices
21 CFR 820 establishes basic requirements applicable to manufacturers of finished medical devices intended for human use in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. This includes finished devices imported into or offered for import in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.