Development of medical devices is highly regulated [1–3]. The U.S. Food and Drug Administration (FDA) provides a guidance stating that reliability should be part of the device performance requirements [4]. Yet the role of reliability testing and analysis varies significantly from one manufacturer to another. In addition, the FDA requires tracking of all medical device failures so ignoring reliability can lead to significant risks for the medical device manufacturer. However, traditional reliability testing can be expensive for complex electromechanical medical devices. With typical volumes of less than 1000 devices a year and large device costs, it is not feasible to build and test large sample sizes. Using a mixture of reliability analysis alongside traditional stress testing can increase confidence in the device and allow for smaller sample sizes and shorter test times.

In this paper, a methodology will be presented for...

References

References
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Department of Health and Human Services, 2005, “Code of Federal Regulations Title 21, Part 820: Quality System Regulation,” U.S. Food and Drug Administration, Washington, DC.
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Council of the European Communities, 1993, “Medical Devices Directive 93/42/EEC,” Official Journal of European Communities, No L 169/1.
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