ISO 14971 2007 MEDICAL DEVICE

RISK MANAGEMENT LIBRARY

Introduction to ISO 14971 Risk Management

Plain English Medical Device Risk Management Definitions

Overview of ISO 14971 Medical Device Risk Management Standard

ISO 14971 Medical Device Standard Translated into Plain English

ISO 14971 2007 in Plain English Table of Contents

Our Plain English Approach

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
can be used to identify hazards, to estimate and evaluate risks, and to
implement and monitor the effectiveness of risk control measures.

OTHER RELATED LIBRARIES

ISO 31000 2009 Risk Management Library

ISO 13485 Medical Device Quality Management Library