Mar 6, 2023
FDA
The new article highlights the aspects related to the declaration of conformity, the applicable certification requirements, and also the information to be shared by the manufacturers with other parties involved in the use of x-ray equipment. Table of Contents The Food...
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Mar 2, 2023
Saudi Arabia
The new article highlights the aspects related to the voluntary consensus standards recognized by the authority, and also to the overlap of the two different regulatory frameworks. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
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Feb 28, 2023
FDA
The article addressed the key points related to x-ray medical devices in the context of applicable standards. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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Jul 7, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to medical device data systems, medical image storage devices, and medical image communications devices. The...
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