More than standards and regulations are needed to provide safe and effective devices.
Medical devices that met standards have been recalled. Quality systems that were said by internal audits to be in compliance with FDA regulations or ISO quality standards received serious questions after external auditing. Devices meeting standards or produced by quality systems felt to be in compliance have put patients at risk by failing at critical moments. Something more than just meeting standards and regulations is needed to provide safe and effective medical devices.
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D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D004869:Equipment Safety / Q000592:standards*; D006801:Humans; D007221:Industry / Q000592:standards; D007391:International Cooperation; D011786:Quality Control; D012308:Risk Management / Q000592:standards; D017751:Safety Management / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration