-
MDR certification is a type of EU CE certification
Under the MDR certification for medical devices, it belongs to a type of EU CE certification, which was formerly known as the EU's medical device CE certification standard. The MDR certification for medical devices was released in May 2020, which is a new version and is intended to replace the mandatory certification for EU medical device CE re···
115
-
FDA510K certification application process cycle
Medical device FDA 510 (k) registration is commonly referred to as 510 (K) registration due to its corresponding FD&C Act Chapter 510. 510 (k) is one of the main channels for medical devices to be launched in the United States, and the vast majority of Class II medical devices and local Class I and III medical devices go through this processCle···
110
