FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the reporting of computational modeling studies in medical device submissions. The latest version of...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has issued a guidance document dedicated to the procedures for handling post-approval studies imposed by premarket approval application orders. The...
Europe
Medical devices in Italy are subject to the same regulations as all countries in the European Union (EU) which were implemented in 2017. Here, you can find out more information on the EU MDR and IVDR regulation. However, there are slight differences in the regulatory...
Europe
Medical devices in the EU, including Hungary, are classified into four classes based on their risk: I, IIa, IIb, and III. Medical devices belonging to Class I are associated with the lowest risk to the human body, while Class III devices are associated with the...
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