ISO 14791 PDF

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. Document your medical device risk management plan.

ISO 14971 Risk management for medical devices

Define the scope of your risk management activities. Assign risk management responsibilities and authorities.

Specify management review requirements. Establish risk acceptability criteria for each plan. Establish a risk management file for each medical 1471. 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.

ISO – Medical devices — Application of risk management to medical devices

Evaluate your residual remaining risks see Part 6. Decide if benefits exceed residual 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 lso is practicable. Select the most appropriate risk control measures.

ISO 14971 – Risk Management Application to Medical Devices

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 device monitoring system. This page summarizes the ISO standard. It highlights the main points. It does not present detail. Title 48 is 60 pages long and comes in pdf and doc file formats.


ISO Ios Library. A to Z Index. Updated on November 28, First published on February 28, Legal Restrictions on the Use of this Page Thank you for visiting this webpage.

You are welcome to view our material as often as you wish, free of charge. And as long as you keep intact all copyright notices, you are also welcome to print or make one copy of this page for your own personal, noncommercialhome use. Review your risk management 144791.