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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Original Message:
Sent: 17-Mar-2023 03:20
From: Noopur Gupta
Subject: Reliability testing
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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