Medical Device Reporting (MDR) 21 CFR Part 803
Medical Device Reporting 21 CFR 803 • §803.3 Serious Injury An injury or illness that: 1.Is life-threatening 2.Results in permanent impairment of a body function or permanent damage to a body structure 3.Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure ................
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