ISO 14971 Risk Management for Medical Equipment - Part 2


  • => Define your risk management process
  • => Establish management rules and responsibilities
  • => Document the risk management plan
  • => Establish a live risk management file
  • => Understand and define the scope of your device and document the intended use
  • => Identify the potential sources of damage associated with your product. This is known as danger
  • => Estimate the risk of each dangerous situation.
  • => Risk is the combination of the severity of the potential damage and the probability of the damage occurring
  • => Are the risks at an acceptable level?
  • => Is risk reduction necessary?
  • => Use risk control to reduce risk to acceptable levels.
  • => Assess the risk of the product in its entirety.
  • => Is the risk level acceptable?
  • => Does the benefit outweigh the potential risks?
  • => Perform a risk management analysis and prepare a risk management report before sending your device to commercial production.
  • => Internal auditing, Preventive and corrective actions, compliance, customer feedback, material non-compliance, all sources in the risk management process.
  • => Risk management is a process for the entire product life cycle.

In the next publication, I will write about practical tips for a good risk analysis meeting.Leave your comment and until the next post.

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