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Search results with tag "Medical device reporting"
MDR: Failures, Successes and Solutions
fmdic.orgMedical Device Reporting Regulation Medical Device Reporting (MDR, 21 CFR Part 803) Establishes the reporting requirements for device user facilities, manufacturers and importers. A mechanism for FDA and manufacturers to identify and monitor significant adverse events
Medical Device Reporting (MDR) 21 CFR Part 803
fmdic.org4 Medical Device Reporting 21 CFR 803 • §803.3 MDR Reportable Event means 2.An event that manufacturers or importers become aware of that reasonably suggests that