A brief walk-through of ISO medical device risk management in plain English & overview of key definitions and concepts. –The standard cross references ISO for guidance related to Courtesy of ISO “Medical Devices -= Application of risk management to. ISO (E). PDF disclaimer. This PDF file may contain embedded typefaces. In accordance with Adobe’s licensing policy, this file may.
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ISO is a risk management standard for medical devices.
ISO – Medical devices — Application of risk management to medical devices
Document your medical device risk management plan. Define the scope of your risk management activities. Assign risk management responsibilities and isso. Specify management review requirements. Establish risk acceptability criteria for each plan.
ISO 14971 Risk management for medical devices
Establish a risk management file for each medical device. Use your risk management file to facilitate traceability. Maintain a risk management file for each medical device. Perform a risk analysis for each medical device. Estimate the risk for each hazardous situation. Record your risk analysis activities and results. Reduce risk whenever your risk is unacceptable. Identify your risk control options see Part 6.
Implement appropriate risk control options see Part 6. Evaluate your residual remaining risks see Part 6. Decide if benefits exceed kso risks see Part 6. Identify risks arising from risk controls see Part 6. Ensure that all risks were considered see Part 6. Identify risk control measures that reduce risk to an acceptable level.
Determine whether or not risk reduction is practicable. Select the most appropriate risk control measures. Implement all of your risk control measures. Verify that each risk control was actually implemented.
Develop your medical device monitoring system. Use your medical device monitoring system.
Document your medical device monitoring system. Maintain your medical isoo monitoring system. This page summarizes the ISO standard. It highlights the main points. It does not present detail.
ISO Risk management for medical devices | BSI Group
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Review your risk management process.