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Comprehensive yet concise reference edition to assist in the application of Risk management for medical devices. ISO 14971, is an established standard that is recognized worldwide by regulators. It is acknowledged as being the principal standard to use when performing Medical Device Risk Management. PART 1: RISK MANAGEMENT Introduction Basic terms and definitions General Requirements Regulations and Standards Regulation2017/745 (EU MDR) U.S. Food and Drug Administration (FDA) Health Canada Medicines and Healthcare products Regulatory Agency Japan MHLW Australian Therapeutic Goods Administration (TGA) ISO 13485 ISO 16142-1 2017/745 (EU MDR) & Risk Management GHTF & Risk Management Risk Analysis Reasonably foreseeable misuse Identification of characteristics related to safety Identification of hazards and hazardous situations Hazardous Situations Risk Analysis Techniques Preliminary Hazard Analysis (PHA) Fault Tree Analysis (FTA) Failure Mode and Effects Analysis (FMEA) Hazard Analysis and Critical Control Point (HACCP) Risk Estimation / Evaluation Probability Risk Estimation Risk Control Risk Acceptability Criteria for risk acceptability Evaluation of overall residual risk and acceptability Criteria for risk acceptability Role of Management Risk Management Plan Risk Management Plan inputs Risk Acceptability Method to evaluate overall residual risk Verifications methods and activities Post production and Post Marketing Requirements Risk Management Review and Reporting Severity Risk Management File Overall Residual Risk Benefit-risk analysis Criteria of benefit-risk analysis Residual Risk Post Production Review FMEA, Failure Mode and Effects Analysis Risk Management and Role of Standards ISO 16142-1 Essential Principles relating to Risk ISO/IEC Guide 63 IEC 62366-1 ISO 10993-1 ISO 14155 Usability Engineering and Medical Devices Product Realization Process and Risk Management PARRT II: FAILURE MODES AND EFFECTS ANALYSIS (FMEA AND FMECA) Introduction Why FMEA Methodology Key topics: ISO 14971 guidance, Risk Management Plan, FMEA/FMECA methodology, EU MDR compliance, FDA/Health Canada/MHLW/TGA regulations.