Failure Mode and Effects Analysis (FMEA)

   Failure Tree Analysis (FTA)

   Monitoring after listing (customer complaints, etc.)

  Clinical Experience

   Some examples of risk management according to ISO14971:

  . Intended use of the device

  . Anticipated contact with patients and third parties

  . Risks related to materials/components used in the device

  . Energy supplied to or from the patient

  . Devices manufactured under sterile conditions

  . Devices for changing the patient's environment

  . Instructional instruments

  . Devices used to control or be used in conjunction with other devices or drugs

  . Devices whose output of unwanted energy or matter is susceptible to environmental influences

  . Instruments with important consumables or accessories

  . Necessary routine maintenance and correction

  . Devices containing software

  . Devices with limited shelf life

  . Delayed or long-term use may cause ordinary risks

   All applicable items must address possible hazards and ways to reduce them.

   Demonstration of risk reduction: warning in the instruction manual.