ISO 14971 Medical Device Risk Management Library

ISO 14971 is a risk management standard for medical devices. It defines
a set of risk management requirements. The purpose of ISO 14971 is to help
manufacturers to establish a medical device risk management process that
they can use to identify hazards, to estimate and evaluate risks, and to
implement and monitor the effectiveness of risk control measures.

Introduction to ISO 14971 Risk Management

Overview of Medical Device Risk Management Standard

Medical Device Risk Management Standard in Plain English

Plain English Medical Device Risk Management Definitions


ISO 31000 2009 Risk Management Guide

Risk Assessment Procedures and Methodologies

ISO 13485 Medical Device Quality Management Guide

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Updated on March 2, 2017. On the Web since May 25, 1997.

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