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.
Status : WithdrawnPublication date : 2007-03
Corrected version (en) : 2007-09
Corrected version (fr) : 2007-09
Edition : 2Number of pages : 82
Technical Committee:Quality management and corresponding general aspects for medical devices