Surgical Sutures 510(k)

  SURGICAL SUTURES 510(k)PROCESS   The 510(k)-submission process is a premarket notification process required by the United States Food and Drug Administration (FDA) for certain medical devices. The purpose of the process is to demonstrate how surgical sutures are substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and…

medical device labelling

Medical Device Labelling Requirements

[A]  Non-Active Medical Device Labelling  Information on the EU MDR Medical Device Labelling Requirements  Name or trade name of the device. Necessary details for a user to identify the device, the contents of the packaging, and the intended purpose of the device. The name, registered trade name or registered trademark, and the address of its…