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Bringing a medical device to market in the United States requires navigating a complex regulatory landscape, primarily regulated by the Food and Drug Administration (FDA). Understanding the classification, regulatory pathways and compliance requirements is critical to success. At D.med Technologies,...

this is the Excerpt. The last decades have been surrounded by many cybersecurity attacks around the world, many of them in Hospitals or Medical Devices. For example, on September 12th, 2022, the FBI warned that many medical devices with outdated...