ISO 14971 regulation is directly co-related to with Risk Management, a system implemented to identify hazards and initiate a preventative action to ensure the medical device meets the regulatory requirements. Risk management revolves between a Risk Analysis procedure and FMECA to ensure the device does not cause potential harm. Within Risk Management it also enforces the company of the said medical device to keep track of all complaints to ensure that it does not initiate a CAPA. Risk Management is worked parallel with design controls and is attached to the DHF, however can be edited and placed with the DMR when it comes to monitoring the device post production.