Innovit Client Completes M2M Tests with AusUDID and EUDAMED
The European Union in recognizing the pivotal role played by the EUDAMED system in safeguarding patient safety and efficiency of medical devices within the market…
Innovit Client Completes M2M Tests with AusUDID and EUDAMED
Sharing information about products and devices is a cornerstone of modern supply chains, regulatory compliance departments and ecommerce platforms. There are several options to facilitate this sharing, from point-to-point implementations to more dispersed methods that allow multiple connections to utilize the same information, such as the Global Data Synchronization Network (GDSN).
The Risks of Last-Minute Device Registration – And How to Avoid Them
The European Union in recognizing the pivotal role played by the EUDAMED system in safeguarding patient safety and efficiency of medical devices within the market…
EUDAMED Go-Live Announcement: Streamlined UDI Data Submission using Innovit EUDAMED Connector
The European Union in recognizing the pivotal role played by the EUDAMED system in safeguarding patient safety and efficiency of medical devices within the market…
Updated Timeline: Mandatory Use by Q4 2025 – Current planning for gradual roll out and modules’ functionality view
The European Union in recognizing the pivotal role played by the EUDAMED system in safeguarding patient safety and efficiency of medical devices within the market…
MDR Third Amendment is official: EUDAMED Mandatory Use by January 2026
Source: EU Commission | Directorate-General for Health and Food Safety | Sante > Updated Timeline - Current planning for gradual roll out and modules’ functionality view With the Third Amendment to the European Union’s Medical Device Regulations (MDR) now...
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...
Providing UDI data to Hospitals & GPOs Part 3
As a company, we didn’t do business with Group Purchasing Organizations (GPOs). Our strategy was to have a direct relationship with the customer. However, with UDI data, that changed.
Providing UDI data to Hospitals & GPOs Part 2
Shortly after the FDA published the deadline for submitting UDI product information for Class II devices, I received an email from one of our sales representatives asking for help in submitting UDI data to one of our clients, a healthcare network consisting of several hospitals, medical centers, clinics, and a university health center.
Providing UDI data to Hospitals & GPOs Part 1
As with most medical device companies, our journey into the world of UDI began with the introduction of new FDA requirements to publish product data with a unique number assigned to the product, such as a Global Trade Item Number (GTIN), in the FDA database.