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Get Ready for UDI: It’s All About the Data

Orthopaedic OEMs will be among the first to comply with FDA's unique device identification requirements once finalized. However, the complex nature of UDI means OEMs can’t wait for the final announcement to put processes in place.

Mar 05 2013, Karen Conway

Regulations

UDI Update: Prepping for the Final Ruling

OEMs should be asking, and answering, these 11 questions in anticipation of FDA’s final ruling on UDI guidelines.

Jul 10 2013, Karen Conway

Regulations

Unique Device Identification: From Compliance to Value

FDA issued a proposed Unique Device Identification rule requiring manufacturers of medical devices to uniquely identify their products.

Oct 04 2012, Karen Conway

Market Forces

Industry’s Achilles Heel: The Supply Chain

The implantable device supply chain is ripe with more than $5 billion in inefficiencies in the U.S. alone. This knowledge provides a unique opportunity for medical device manufacturers and their customers to collaborate in reducing these costs.

Aug 05 2013, Karen Conway

Regulations

Unique Device Identification (UDI): Many Questions Remain

FDA issued its final rule requiring medical device manufacturers to assign and label products with UDIs more than a year ago. However, many questions remain for orthopaedic and spine manufacturers.

Dec 10 2014, Karen Conway

Guidance

Voices from OMTEC 2013

Orthopaedic device manufacturers, suppliers and industry experts met at OMTEC to discuss how to mitigate regulatory, manufacturing and supply chain challenges. Here are a few of the important conversations you may have missed.

Aug 02 2013, BONEZONE Editors

Supplier News

GHX Announces UDI Solution

GHX will offer an industry solution that enables manufacturers to publish data to FDA’s Global UDI Database (GUDID) through a...

Jan 22 2014, BONEZONE Editors

Get Ready for UDI: It’s All About the Data

UDI Update: Prepping for the Final Ruling

Unique Device Identification: From Compliance to Value

Industry’s Achilles Heel: The Supply Chain

Unique Device Identification (UDI): Many Questions Remain

Voices from OMTEC 2013

GHX Announces UDI Solution

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