Regulatory Open Forum

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  • 1.  Reliability testing

    Posted 17-Mar-2023 03:20

    Is it a requirement to test reliability along with stability of the medical device?

    Or do we consider reliability as a business criteria and does not need a requirement to be tested?



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    Noopur Gupta
    Brønshøj
    Denmark
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  • 2.  RE: Reliability testing

    Posted 17-Mar-2023 10:16

    Consider stability as a specific instance of reliability dealing with wear-out failures. Generally, stability failures are not repairable, so stability is measured by Mean Time To Fail, MTTF. A good reliability program would determine the failure distribution and the variability.

    However, a general reliability program, such as determining random failure rates, is not, to the best of my knowledge, part of any regulatory requirements. However, if your company makes reliability claims, then regulators will expect you have a program in place to support the claim.

    Also, many companies get confused between risk management, 14971, and reliability, because they make the assumption that patient or user can occur only with a device failure. This is not the intent of the standard which considers hazards in normal or fault conditions. Also, good design practices include the concept of fail safe so that device failures are not likely to result in harm.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 3.  RE: Reliability testing

    Posted 18-Mar-2023 13:49

    Thank you Dan



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    Noopur Gupta
    Brønshøj
    Denmark
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  • 4.  RE: Reliability testing

    Posted 17-Mar-2023 13:55

    Hi Noopur, 

    Reliability and stability are both important characteristics of medical devices that need to be evaluated during their development and throughout their lifecycle. While stability refers to the ability of a device to maintain its physical and chemical properties over time, reliability refers to the ability of a device to perform its intended function consistently and without failure.

    Reliability is critical for medical devices, as it directly impacts patient safety and health outcomes. Therefore, it is essential to test the reliability of a medical device as part of its development process and during its lifecycle. Reliability testing helps to identify potential failures, assess the likelihood and consequences of such failures, and implement corrective actions to reduce risks and improve device performance.

    In summary, reliability testing is not just a business criteria, but a requirement for medical devices to ensure patient safety and efficacy.



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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
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  • 5.  RE: Reliability testing

    Posted 18-Mar-2023 13:50

    Thank you Rajeshwari for taking the time to write this. Its very useful

    Do you know if there is a regulation/standard where I can find these statements related to reliability testings and requirements?



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    Noopur Gupta
    Brønshøj
    Denmark
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