FDA
The article addresses the aspects related to the existing legal framework associated with AST system devices and highlights the key points to be considered. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
FDA
The article provides an overview of the regulatory requirements set forth under the existing framework and highlights the key points associated thereto. Table of Contents The FDA, the US healthcare product regulatory authority, has released a guidance document...
FDA
This article highlights 21 CFR part 11, its scope, applicability and effective ways to maintain regulatory compliance. Table of Contents 21 CFR Part 11 is a regulation introduced by the United States Food and Drug Administration (FDA) that sets forth the criteria...
FDA
The article addresses the aspects related to the approach medical device manufacturers should apply when assessing the actual performance of their products placed on the market in the context of the Voluntary Improvement Program. Table of Contents The Food and Drug...
FDA
The new article highlights the aspects related to the general approach to the changes related to software products and also describes the most important concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
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