Sep 21, 2023
MHRA
The new article describes in detail various specific aspects related to the regulatory requirements that in vitro diagnostic medical devices are subject to. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority,...
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Sep 21, 2023
FDA
The article provides a general overview of the regulatory requirements, and also briefly describes the key concepts. Table of Contents The United States Food and Drug Administration has released a guidance document about Off-The-Shelf (OTS) software used in...
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Sep 21, 2023
MHRA
The new article highlights the aspects related to conformity assessment of In- Vitro Diagnostic medical devices. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has...
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Mar 19, 2022
Saudi Arabia
The article provides an overview of the regulatory requirements for innovative medical devices intended to be marketed and used in Saudi Arabia. Table of Contents The Saudi Food & Drug Authority (SFDA), the country’s regulatory agency in the...
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May 29, 2019
North America
Artificial intelligence (A.I.) is an advanced field of science that has influenced various areas. The concept of implementing artificial intelligence in the healthcare has only recently been emerging. The medical field aims to use the power of A.I. to provide more...
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