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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Apr 17, 2023
FDA
The article highlights the key points related to monitoring clinical investigations as prescribed by the applicable legislation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
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Apr 17, 2023
FDA
The article describes in detail the aspects related to the way in which comparison to a similar medical device already placed on the market is to be provided, and also on the labeling requirements to be fulfilled to ensure all the important information related to the...
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Apr 13, 2023
Africa
The new article addresses the aspects related to specific rules for medical devices with a measuring function or the ones intended to be sterile. The document also describes the general approach to be followed when applying classification rules. Table of Contents The...
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Apr 10, 2023
FDA
The new article describes in detail the aspects related to the applicability of recommendations provided in the guidance in terms of medical devices and regulatory pathways. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
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