by Innovit Corporate Affairs | May 28, 2019 | Blog, Eudamed
As it prepares to meet new regulatory requirements in Europe, the medical device community is following developments regarding the European Database for Medical Devices (Eudamed). Most recently, the European Commission (EC) released three documents for Medical Device...
by Innovit Corporate Affairs | May 21, 2019 | Blog, UDI
Recently, the FDA issued the final guidance, “Unique Device Identification: Convenience Kits” to help clarify the FDA’s policy related to UDI considerations for medical procedure kits. The intent of this guidance is to ensure that the exception for UDI labeling of...
by Innovit Product Team | Mar 12, 2019 | Blog, UDI
Manufacturers of medical devices and companies that supply them must provide products and services that are both safe and effective. And today’s mounting list of regulations, medical device compliance is important to the success of every medical device manufacturer....
by Innovit Corporate Affairs | Jun 26, 2018 | News
Innovit, a global master data management solution provider, is releasing the Unique Device Identification (UDI) Multi-Connector solutions, helping medical device manufacturers keep pace with regulatory compliance standards....
by Innovit Corporate Affairs | Jun 11, 2018 | Blog, UDI
In 2013 the Food and Drug Administration issued a final rule setting out a system for Unique Device Identifiers, or UDIs, that should be applied to medical devices. These UDIs must be in both plain text and a format that can be read by a machine, such as a bar-code....