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Reliability of Manufactured Products | FDA

    https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/reliability-manufactured-products
    During this period the failure rate is relatively constant and failures are caused mainly by stress. Depending on the make-up of the product in question, stress can be temperature, voltage,...

Medical Device Reporting (MDR): How to Report Medical …

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
    The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain …

Failure Analysis of Medical Devices | SpringerLink

    https://link.springer.com/article/10.1007/s11668-021-01332-2
    Most important, the failure of a medical device is not necessarily equivalent to a faulty or defective device; further, device failure does not necessarily mean …

Medical devices have caused more than 80,000 deaths …

    https://www.statnews.com/2018/11/25/medical-devices-pain-other-conditions-more-than-80000-deaths-since-2008/
    The FDA acknowledges its data has limitations, including mistakes, omissions and under-reporting that can make it difficult to determine whether a device …



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