ISO 14971:2007, Medical devices - Application of risk management to medical devices
Book Details
Author(s)
ISO/TC 210
ISBN / ASIN
B008S7KMTQ
ISBN-13
978B008S7KMT7
Availability
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Sales Rank
#2,664,407
Marketplace
United States 🇺🇸
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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.
