Latest blog posts
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 >Â ...
TGA’s Australian UDI Database: Deadline Update
Australia's healthcare landscape is on the brink of a transformative change with the imminent...
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.
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
The 12 Most Important Steps to Global UDI Compliance
The Staggering Number of Global UDI Requirements...
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.
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.
Search by Authors
