ISO 14971:2007 is the most advanced international standard and is quickly recognized as the best procedure for risk management throughout the life cycle of medical device products.

   ISO14971 for risk management is used to help manufacturers bring safe medical devices to the market. Manufacturers are not only responsible for identifying and controlling the risks of the medical devices they manufacture, but also assessing the risks associated with interworking with other devices. The standard also allows other medical production organizations to use the procedure [and obtain certification]. May include human tissue, animal health products, pharmaceutical factories, etc., which may choose this standard.

   This standard requires senior managers to demonstrate their commitment to risk management:

   build the program,

   rules specifying acceptable risk,

   Regularly check the effectiveness of the program.