<p>ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including <i>in vitro</i> diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.</p>
<p>The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.</p>
Registration number (WIID)
38193
Scope
<p>ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including <i>in vitro</i> diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.</p>
<p>The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.</p>
