Sep 22, 2023
FDA
The article provides a general overview of the Risk Assessment and Software testing for Off-The-Shelf Sftware as given by FDA. Table of Contents The United States Food and Drug Administration has released a guidance document about Off-The-Shelf (OTS) software...
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Sep 21, 2023
FDA
The article provides a general overview of the regulatory requirements, and also briefly describes the key concepts. Table of Contents The United States Food and Drug Administration has released a guidance document about Off-The-Shelf (OTS) software used in...
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Feb 15, 2023
FDA
Medical devices are an essential component of modern healthcare, and their safety and efficacy are crucial for the well-being of patients. To ensure that medical devices are safe for use and meet certain quality standards, the Food and Drug Administration (FDA) in the...
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