by Innovit Corporate Affairs | Jul 29, 2022 | Blog, Michelle Laurion
On July 22, the FDA posted its final guidance regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The guidance document, “Unique Device Identification: Policy Regarding...
by Innovit Corporate Affairs | Sep 4, 2021 | Blog
EUDAMED timelines are quickly approaching, and UDI data preparation is no easy task. Preparing early with a master data strategy will make all the difference when mandates for EUDAMED and other health authorities come due. A large component of that strategy centres...
by Innovit Corporate Affairs | Sep 4, 2021 | Blog, Eudamed
The European Commission recently sent out an update on the plan for implementation and roll-out of EUDAMED, as it stands today. Changes to the implementation timeline of different modules, and how they will affect the application of each aspect of MDR are outlined...
by Innovit Corporate Affairs | Oct 28, 2020 | Blog, Eudamed
EUDAMED go-live date is still scheduled for May 2022. In order to ensure a smooth and effective implementation, the EU COM is providing a “EUDAMED playground” available for both manual web‑based user access and an automated M2M (machine‑to‑machine) Data Exchange for...
by Innovit Corporate Affairs | Sep 23, 2020 | News
San Francisco, CA (September 23, 2020) Innovit, a global software company specializing in UDI compliance, Global Data Synchronization (GDSN), Master Data Management (MDM) and Product Information Management (PIM) solutions, has announced today that B. Braun Medical...
