Risk management is considered to be an essential requirement for medical devices under Medical Device Directive, ISO13485 and FDA Quality System Regulation (QSR).

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EN ISO 14971: Application of risk management to medical devices Has been formally recognized by FDA and by Health Canada; the European Union has adopted it as a harmonized standard; Japan has designated it as a Japanese Industrial Standard; and Australia has made it their "de facto" standard for risk management.

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Purpose is to determine the possible risks associated with the use of a medical device in order to anticipate the design, manufacturing, inspection, controls and/or labelling indications required to reduce the risk of product failure for the end-user and patient as low and as far as possible.