ISO 1497:2007 “Applications of Risk Management to Medical Devices” is, as its title indicate, an international standard for risk management of medical devices.

It is recognized by FDA, European authorities, Health Canada and the Australia TGA.

It is an integral part of a quality system and should be incorporated into the design and development process.

The purpose of this document is to establish, document and maintain a risk management process to:

  • Review the intended use of the medical device
  • Identify hazards and estimate the probability that harm might occur
  • Estimate the severity of each hazard and evaluate the associated risk.
  • Control those risks and monitor the effectiveness of the controls put in place.

Overall, most medical device companies find adopting ISO 14971 to be challenging. Let us work with you to integrate this requirement into your quality system.


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