Oct 4, 2023
GMDN
This aticle highlights the importance of Medical Devices in the healthcare industry highlighting their key uses, developments and emerging technologies in the sector. Table of Contents Over the past few decades, there has been a significant evolution in medical...
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Oct 4, 2023
BfArM
The new article addresses the aspects related to the directory containing information about any and all digital health applications available in Germany. Table of Contents The German regulating authority in the sphere of healthcare products (BfArM) has published a...
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Sep 27, 2023
BfArM
The new article provides a general overview of the key points related to the inclusion of digital health products in the respective register. Table of Contents The German regulating authority, the Federal institute for Drugs and Medical Devices (BfArM) in the sphere...
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Apr 20, 2020
FDA
The Food and Drug Administration (FDA) issued guidance dedicated to the digital health devices used to treat psychiatric disorders in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus” and...
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Jun 5, 2019
North America
Pre-cert Program, or also known as the Software Precertification Pilot Program (Pre-Cert), was first mentioned in the FDA’s Digital Health Innovation Action Plan. The purpose of this pilot program is to create a foundation for digital health regulation that is able to...
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