EUDAMED Timeline: Mandatory Use by Q4 2025
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.
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.
Innovit Client Completes M2M Tests with AusUDID and EUDAMED
Innovit is thrilled to announce that one of our customers, a global medical device company and leader in new product development and medical education in orthopedics, was the first to successfully complete M2M testing with AusUDID and one of the first to also successfully complete M2M EUDAMED testing.
The 12 Most Important Steps to Global UDI Compliance
The Staggering Number of Global UDI Requirements Demand Immediate Action in 2023Â The importance of accurately managing product data is evident in healthcare. After all, most of these products have a direct impact on people's health: Things like heart valves,...
Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 2)
Welcome back! If you missed our 2022 re-cap in part one of this blog series, you can find it here. If you’re already caught up…
Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 1)
Medical Device Manufacturers in the US have many questions as the Dec 8, 2022 GUDID compliance deadline approaches. This blog will answer some of the most common questions, and ensure everyone has the answers they need to begin their journey toward the FDA’s GUDID Class I Compliance.Â
FDA Class I GUDID Compliance Regulation FAQ’s
Medical Device Manufacturers in the US have many questions as the Dec 8, 2022 GUDID compliance deadline approaches. This blog will answer some of the most common questions, and ensure everyone has the answers they need to begin their journey toward the FDA’s GUDID Class I Compliance.Â