Apr 10, 2023
FDA
The document highlights the key points related to the regulatory requirements for certain orthopedic devices based on the draft guidance issued by the authority. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulatory agency in the...
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Apr 6, 2023
EU MDR/IVDR
Medical devices are an integral part of healthcare, and their safety and efficacy are critical to ensure patient well-being. In 2017, the European Parliament and Council adopted the new Medical Devices Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) to...
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Mar 30, 2023
FDA
The new article highlights the aspects related to the special framework allowing face masks intended for a medical purpose to be placed on the market under a simplified procedure. Table of Contents Introduction The Food and Drug Administration (FDA or the Agency), the...
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Mar 30, 2023
FDA
The new article describes in detail the regulatory policy to be applied with respect to certain medical devices used in the context of the pandemic. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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Mar 23, 2023
FDA
The article provides an overview of the regulatory approach to be applied with respect to certain medical devices used in the context of the pandemic. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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