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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 14971 Risk Management Requirements for Medical Devices

Risk management is a key component in demonstrating regulatory compliance for medical devices. The manufacturer must apply all the “control options” and may not stop his endeavours if the first or the second control option has reduced the risk to an “acceptable level” unless the additional control option s do es not improve the safety Deviation as to the first risk control option.

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The Medical Devices Directive Annex ZA The content deviation lists seven aspects that have been identified where the standard deviates or might be misunderstood as deviating from the Essential Requirements.

Identify risks arising from risk controls see Part 6. Develop your medical device monitoring system. All risks have to be reduced as far as possible and that all risks combined, 114791 of any “acceptability” assessment, need to be balanced, together with all other risks, against the benefit of the device Risk reduction “as far as possible” versus “as low as reasonably practicable”.


Manufacturers and Notified Bodies may not apply the ALARP concept with regard to economic considerations Discretion as to whether a risk-benefit analysis needs to take place. The risk management process presented in ISO includes:. As such, compliance 147991 the provisions of ISO is essential for manufacturers of medical devices seeking regulatory approval in the U.

ISO 14971 – Risk Management Application to Medical Devices

Perform a risk analysis for each medical device. Use your risk management file to facilitate traceability.

Evaluate your residual remaining risks see Part 6. Define the scope of your risk management activities. ISO standards by standard number. Implement ideal methods of reducing risk for all stakeholders Develop devices and therapies that are proven effective in the industry Manage speed and cost to market Optimize speed of iteration Streamline the regulatory process that will enable entry to selected markets EN ISO These and other benefits can result in faster time to market, and greater competitive advantages.

X Find out what cookies we use and how to disable them. The annexes have identified some of the key deviations between the standard and the Essential Requirements. This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle.


ISO standards Regulation of medical devices Medical technology. This was done to address the presumed compliance with the 3 Directives that is obtained through notified body certification audits and regulatory submissions that claim compliance to ido standard.

Testing for device usability and functional safety are also available. Document your medical device risk management plan. The risk management process presented in ISO includes: Decide if benefits exceed residual risks see Iiso 6. Your benefits at a glance. A to Z Index. For certain types of medical devices, an effective risk management evaluation will also identify risks associated with device reprocessing and reuse.

Determine whether or not risk reduction is practicable.

Record your risk analysis activities and results. The BSI website uses cookies. Identify risk control measures that reduce risk to an acceptable level.

ISO Risk Management Requirements for Medical Devices | TÜV SÜD

This page summarizes the ISO standard. Quality system certification and auditing expertise – Medical device approvals routinely require the implementation of a quality management system.

You are welcome to view our material as often as you wish, free of charge. To ensure your company gets a safe, effective product to market on time and within budget, you need a successful implementation of your risk management system. This page was last edited on 24 Ixoat