ISO 14971:2009 Risk Management

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.

These requirements are applicable to all stages of the life-cycle of a medical device. The standard requires that top management demonstrate its commitment to risk management by; a) establishing the process, b) setting the policy for acceptable risk, and c) reviewing the effectiveness of the process at determined intervals. TechLink International offers a training program focused on this aspect to ensure compliance to all standards.