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
Manufacturer Multiple. Distributed through American National Standards Institute (ANSI)
Binding Paperback
ItemPartNumber inhan-aami-130
ReleaseDate 2010-11-02

Country	USA
Manufacturer	Multiple. Distributed through American National Standards Institute (ANSI)
Binding	Paperback
ItemPartNumber	inhan-aami-130
ReleaseDate	2010-11-02

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