This presentation will examine the requirements of IEC 60601-1 for use of ISO 14971 risk management and interpret those requirements. In addition, there will be practical examples of application and documentation of risk management activities in a manner that meets IEC 60601-1 and ISO 14971 requirements.
                                
                                            
 
             
             
                             
                         
                         
                                 
                                         
                                                                                                     
                 
            