Thanks! You've successfully subscribed to the BONEZONE®/OMTEC® Monthly eNewsletter!

Please take a moment to tell us more about yourself and help us keep unwanted emails out of your inbox.

Choose one or more mailing lists:
BONEZONE/OMTEC Monthly eNewsletter
OMTEC Conference Updates
Advertising/Sponsorship Opportunities
Exhibiting Opportunities
* Indicates a required field.

Articles written by Karen Conway

Unique Device Identification (UDI): Many Questions Remain

by Karen Conway | Dec 2014

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. ... Read more »

Industry’s Achilles Heel: The Supply Chain

by Karen Conway | Aug 2013

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. ... Read more »

UDI Update: Prepping for the Final Ruling

by Karen Conway | Jul 2013

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

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

by Karen Conway | Mar 2013

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. ... Read more »

Unique Device Identification: From Compliance to Value

by Karen Conway | Oct 2012

It took five years, but the U.S. FDA has finally issued the proposed Unique Device Identification rule that will require manufacturers of medical devices to uniquely identify their products and populate FDA’s global UDI database. Orthopaedic manufacturers will be among the first impacted ... Read more »