Regulatory Update: Australia’s UDI Regulation Now in Effect
We’re pleased to share that Australia’s Unique Device Identification (UDI) regulatory framework is now officially in effect, marking a major milestone in strengthening patient safety and medical device traceability. The Therapeutic Goods Legislation Amendment...
TGA’s Australian UDI Database: Deadline Update
Australia's healthcare landscape is on the brink of a transformative change with the imminent launch of the Australian Unique Device Identification (AusUDID) database by the Therapeutic Goods Administration (TGA). With the AusUDID set to go-live in the second quarter...
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
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...
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...
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,...
PRESS RELEASE: B. Braun goes Live with Innovit direct GUDID connector
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...