quality system management / supply chain / given product / regulators healthcare facilities healthcare providers hospital biomedical engineering / risk management / patients users regulators healthcare facilities healthcare providers hospital / manufacturing / decision analysis tool / informal working / healthcare / particular device / cases non-conforming products / decisions about medical device / similar devices / vs. multiple use device / backup systems / users regulators healthcare facilities healthcare providers hospital biomedical / /
MedicalCondition
international / local diseases / injury / infectious and contagious diseases / immediate injury / unexpected new infectious and contagious diseases / prior adverse events Chronic / infectious disease / /
Organization
FDA / U.S. Food and Drug Administration’s Center for Devices / Decision Education Foundation / U.S. Food and Drug Administration’s Center for Devices and Radiological Health / Foundation for Risk Assessment and Risk Management In / Association for the Advancement of Medical Instrumentation / Radiological Health / /
Risk Principles and Medical Devices: A Post-Market Perspective White Paper Draft