North America
The medical device regulating authority in the United States, the FDA, issued special warning on cybersecurity threats related to cardiac implantable devices (ICDs). According to the document placed on the official website, the FDA aims to alert both companies and...
Europe
Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to bring a device to market. These regulations are generally quite complex, but such complexity...
EU MDR/IVDR
MEDICAL DEVICE REGULATIONS IN FINLAND Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to bring a device to market. These regulations are...
Europe
In Croatia, the governmental body responsible for regulating medical devices is the Agency for Medicinal Products and Medical Devices (HALMED). Devices are categorized into the following classes based on the risk they pose toward on the human body: Class I, Class IIa,...
EU MDR/IVDR
Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to bring a device to market. These regulations are generally quite complex, but such complexity...
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