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.

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 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.

Latest blog posts

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...

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.

EUDAMED Timeline: Mandatory Use by Q4 2025

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.

Providing UDI data to Hospitals & GPOs Part 2

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

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 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.

PODCASTS / VIDEOS

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

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

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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