In the design and development of safe, effective medical devices, reducing risk and ensuring reliability are a manufacturer's primary responsibility. Not only are these dimensions of product quality mandated by various national and international organizations, they are a moral and ethical imperative due to the significant impact that medical devices can have on human lives.     

 

A detailed, systematic process for risk management is defined in international standard ISO 14971, cited as a best practice in the global document GHTF/SG3, and required by the FDA for the premarket approval of medical devices.         

 

Risk management requires medical device

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