ISO 14971:2007, Medical devices - Application of risk

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

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.

Country	USA
Author	ISO/TC 210
Binding	Paperback
Label	Multiple. Distributed through American National Standards Institute (ANSI)
Manufacturer	Multiple. Distributed through American National Standards Institute (ANSI)
NumberOfPages	90
PublicationDate	2010-11-02
Publisher	Multiple. Distributed through American National Standards Institute (ANSI)
ReleaseDate	2010-11-02
Studio	Multiple. Distributed through American National Standards Institute (ANSI)

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