Risk management.
All of the risk analysis tables, the risk control measures, verification results, risk/benefit analyses, risk evaluations, and traceability analyses need to be documented and available for inspection by auditors. One way to organize this documentation is to have a risk management file that includes or references each of these documents.
D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D004867:Equipment Design / Q000379:methods / Q000592:standards; D019544:Equipment Failure Analysis / Q000379:methods / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*; D016016:Proportional Hazards Models; D012307:Risk Factors; D012308:Risk Management / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards*; D014481:United States