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.
Wes has implemented methodologies with a cornerstone on patient and caregiver safety achieving regulatory compliance, including 21 CFR Parts 11, 210, 211, 803, 806, 820 and 1271. Performed the same for HIPAA, SOX, ISO 9001 and ISO 13485, 14971, and 14969. Hands-on, international experience includes U.S., European Union Countries, Japan (PAL/PMDA) and Australia (TGA).
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.
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.