ISO 14971:2007, Medical devices - Application of risk management to medical devices

Name: ISO 14971:2007, Medical devices - Application of risk management to medical devices
Author: ISO/TC 210
ISBN: 978B008S7KMT7

Author ISO/TC 210

Publisher Multiple. Distributed through American National Standards Institute (ANSI)

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Book Details

Author(s) ISO/TC 210

Publisher Multiple. Distributed through American National Standards Institute (ANSI)

ISBN / ASIN B008S7KMTQ

ISBN-13 978B008S7KMT7

Marketplace France 🇫🇷

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Description

ISO 14971:2007 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 ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

ISO 14971:2007, Medical devices - Application of risk management to medical devices

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