医疗器械风险管理教材.pdfVIP

Risk Management in the Quality System Regulation Asian Harmonization Working Party Pre-Meeting New Delhi, India, November 3-4, 2008 Erin Keith, Materials Engineer Office of Compliance, Center For Devices and Radiological Health U.S. Food and Drug Administration U.S. Department of Health and Human Services Introduction Risk Management Requirements ISO 13485 ISO 14971 Quality System Regulation (21 CFR 820) Risk Based Decisions Quality System Regulation Preamble Introduction Similarities between ISO and FDA Risk Management Requirements Evaluation of Risk Management Systems in a Quality System/GMP Inspection Summary Risk Management Requirements: ISO 13485 7.1 Planning of Product Realization The organization shall establish documented requirements for risk management throughout product realization. Records arising from risk management shall be maintained. Note 3 See ISO 14971 for guidance related to risk management. Risk Management Requirements: ISO 14971 1 Scope This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device. … This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system. Risk Management Process: ISO 14971 R