North America
Mobile health app The growing significance of mobile health apps result in a need to ensure its proper regulation. Practitioners, patients, researchers and medical industries are all affected by mHealth apps. The digital health field is regulated by the FDA under four...
Asia
Learn about what Global Medical Device Regulations regulatory stands for: If you are strong exporter of medical devices, you should know about global medical device regulations. Canada The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the...
North America
Any manufacturer who wants to legally market their medical device in the US intended for human use has to get FDA approval. Any class I, II, or III devices, which is not exempt and does not require premarket approval must fulfill the requirements of a 510(k) of the...
North America
By Priya Bhutani — Obtaining market approval for a medical device from the US FDA seems arduous and frightening and most manufacturers do not know where to even begin. Medical devices are subject to general controls of the Federal Food Drug & Cosmetic...
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