Developing a procedure for serious medical device problem reporting.
Advanced Medical Regulatory Compliance, Dana Point, CA.
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Amtower
D004282:Documentation; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D005568:Forms and Records Control; D016134:Organizational Policy; D010934:Planning Techniques; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D012308:Risk Management / Q000331:legislation & jurisprudence* / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration