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.

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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.

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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.

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Latest blog posts

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…

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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).

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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…

Read More
Innovit Client Completes M2M Tests with AusUDID and EUDAMED

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).

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PODCASTS / VIDEOS

Brazil’s UDI Update: ANVISA plans major medical device registration updates

by  | Sep 25, 2022 | 

Brazil’s medical device market regulator, ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001.

UDI UPDATES

Australian Unique Device Identification (UDI) Framework: Medical Device UDI Implementation, Essential Principles Guidance

Australian Unique Device Identification (UDI) Framework: Medical Device UDI Implementation, Essential Principles Guidance

by | Sep 19, 2022 | , ,

Australia is establishing a unique identification system for medical devices and its regulator, the Therapeutic Goods Administration (TGA) issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles for compliance requirements and guidelines for active medical devices.

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Innovit Corporate Affairs

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Wes Bloemker