Tag: Class I

The Arthrex Journey: Achieving Data Requirements For UDI And Beyond

By | May 2nd, 2018

The next UDI Compliance deadline for Class 1 is September 24, 2020.  We want to make sure you are prepared to meet those requirements and evaluate the breadth of products that impact your company. Many medical device manufacturers, including Arthrex, have already had to prepare for FDA’s UDI and meet compliance dates for Class III […]

UDI: Generating Value Beyond Compliance

By | May 9th, 2017

UDI: Generating Value Beyond Compliance

Getting to Good Data in the GUDID* The United States Food and Drug Administration (FDA) regulation mandates that UDI data for Class I medical devices to be submitted with an impending deadline of September 24, 2020.  This has made medical device manufacturers on a global basis, readying their organizations for compliance. As a leading healthcare […]