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...
read moreDevice 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...
read moreFREE 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...
read moreEUDAMED 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...
read moreAn 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...
read moreEUDAMED 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,...
read moreNEWS: 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...
read morePRESS RELEASE: B. Braun goes Live with Innovit direct GUDID connector
San Francisco, CA (September 23, 2020) Innovit, a global software company specialising in UDI compliance, Global Data Synchronisation (GDSN), Master Data Management (MDM) and Product Information Management (PIM) solutions, has announced today that B. Braun Medical...
read moreInnovit and atrify Renew Global Partnership
Global partnership will focus on providing customers with solutions to share reliable and proven product data with their business partners. SAN FRANCISCO - May 5, 2020 - PRLog -- Innovit, a global software company specialising in UDI compliance (Unique Device...
read moreCOVID-19 Update for Our Customers
Together we face a truly unprecedented situation being the global coronavirus pandemic (COVID-19) and its impact on our families, businesses, and our community way of life. As we continue to monitor the rapidly evolving situation around coronavirus (COVID-19), our...
read more