Oct 5, 2023
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...
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Sep 20, 2023
FDA
The new article addresses the aspects related to modifications to existing medical devices already placed on the market and allowed for use in the US. The document describes in detail various types of changes and explains the way their regulatory status should be...
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Sep 19, 2023
FDA
This article describes in detail the approach to be applied with respect to computational modeling and engineering analysis to be conducted in the course of non-clinical testing of the products in order to assess their materials and characteristics. Table of Contents...
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May 1, 2023
FDA
The new article highlights the aspects related to the applicable policy and outlines the key points to be taken into consideration. Table of Contents The Food and Drug Administration (FDA), the US regulating authority in the sphere of healthcare products, has...
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Apr 18, 2023
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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