Innovit Announces GDSN.cloud Solution
June 7th, 2022 — Innovit, the Product Information Management (PIM) specialists who enable Healthcare Providers and Medical Products Suppliers to deliver trusted product data for supply chain management and clinical performance optimization, today announced their GDSN.cloud solution enabling healthcare manufacturers to easily share accurate & validated product data to the GDSN.
PRESS RELEASE: Innovit and atrify Strengthen Partnership Accelerating Healthcare Manufacturers Ability to Manage and Share Accurate Product Content
San Francisco, CA (June 3, 2022) Innovit, the Product Information Management (PIM) specialists in enabling healthcare providers to deliver trusted data best practices in supply chain and clinical performance and atrify, a leading provider of product content solutions,...
Introducing Innovit’s EUDAMED Reference Center
As a medical device provider one of the biggest changes on the horizon will be the new EU requirements for product information, as well as the FDA’s GUDID compliance deadline for Class I medical devices. Even the most experienced companies uncover critical gaps in...
Device Registration ‘is live’ for voluntary UDI data submission on EUDAMED
Last week, the European Commission announced the successful launch of its EUDAMED “Device Registration” and “NBs & Certificate” modules (Production release “v2.0 - September version” was deployed). The EUDAMED UDI/Device Registration and NBs & Certificates modules...
FREE Early Access to the EUDAMED Test Environment!
Innovit is Excited to Announce Our EUDAMED.cloud Test Environment! To the best of our knowledge, we are the only company offering free access to a EUDAMED testing environment for all medical device manufacturers – helping you stay ahead of the curve for EUDAMED...
EUDAMED Implementation and Roll-Out Timeline Update
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...
An Important Milestone for the Medical Device Community: EU’s MDR-day has Arrived!
After four years of transition followed by a global pandemic in 2020, we reached a regulatory milestone on May 26, 2021 for Medical Device manufacturers in the European Union – with Medical Device Regulation 2017/745 finally taking effect. Yesterday, being the date of application of EU Medical Device Regulation (MDR) marks an important event for the medical devices market.
EUDAMED State of Play – New Playground Available for EUDAMED Device Registration and NBs & Certificates modules
What’s New? EUDAMED go-live date is still scheduled for May 2022. But you may recall that in order to ensure a smooth and effective implementation, the EU Commission provides a “EUDAMED playground.” It’s currently available for both manual web- based user access,...
NEWS: EUDAMED State of Play: EU Commission delays EUDAMED Device Registration Go-live
The EU Commission provides a “EUDAMED playground” available for both manual web-based user access and automated M2M (machine to machine) Data Exchange for Actor Registration, Notified Bodies & Certificates, and Device Registration modules. These testing “playgrounds” are available in different rounds and for specific time periods with test cases for each version.
EUDAMED: Playground Testing Update
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...