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Articles Tagged "UDI"

ConnectSx Launches UDidentify Mobile App

by BONEZONE | Jan 2018

The free app scans and validates HIBCC and GS1 barcodes used for compliance with FDA unique device identification (UDI)... Read more »

UDI Direct Marking Guidance Finalized by FDA

by BONEZONE | Nov 2017

FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account for the wide variety of existing devices, use conditions and reprocessing methods.... Read more »

GS1 Launches Supply Chain Optimization Resource

by BONEZONE | Aug 2017

The GTIN Adoption and Usage Model is a self-assessment tool to gauge progress in usage of Global Trade Item Number.   ... Read more »

What Should Your Supply Chain Look Like in Five Years?

by BONEZONE | Nov 2016

The supply chain has undergone greater scrutiny as stakeholders question how to find efficiency in process and spend. What changes will this spur to ensure success today—and five years from now? Supply chain experts weighed in at OMTEC 2016.... Read more »

Making the Most of UDI

by Chris Mosby | Aug 2016

UDI regulations have altered your business. Gaining solid ROI from your compliance efforts comes down to internal efficiency, capturing your own master data and learning how to use that data for product development, marketing and logistics.... Read more »

FDA Guidance Outlines How to Create a Unique Device Identifier

by BONEZONE | Jul 2016

FDA recommends companies reexamine UDI basics with new draft guidance on how to form a proper identifier.... Read more »

Noxilizer Announces First 510(k) Clearance for a Device Sterilized Using Nitrogen Dioxide

by BONEZONE | Jun 2016

Noxilizer, a sterilization company with a focus on advancing the NO2-based sterilization process for medical device manufacturers, announced FDA 510(k) clearance for a medical device terminally sterilized using Noxilizer’s nitrogen dioxide sterilization process.With this clearance, Noxilizer has e... Read more »

Electron Beam Engineering Offers Laser Marking

by BONEZONE | Apr 2016

Electron Beam Engineering, a precision electron beam and laser beam welding provider, announced it now offers laser marking for etching and engraving into metals and ceramics. The company’s RMI Laser Marker creates detailed line, numbers or other marks on products for tracking and traceabilit... Read more »

FDA Releases UDI Education as Deadline Approaches

by BONEZONE | Apr 2016

FDA released a series of resources to help companies understand GUDID submission, UDI labelling regulations and compliance schedules. The resources include slideshow presentations and video interviews with FDA.... Read more »

Identifiable and Sterile: Trends Driving Device Packaging

by Chris Mosby | Feb 2016

Unique Device Identification (UDI) and sterilization could be driving influences for the orthopaedic device packaging industry in 2016 and beyond. With increased regulatory guidelines in the form of FDA’s guidance UDI: Convenience Kits, along with tightening price pressures, more companies are loo... Read more »

UDI Update: Trays and Kits

by BONEZONE | Jan 2016

FDA released draft guidance for its Convenience Kit exemption, offering orthopaedic device manufacturers more direction on labeling device trays and kits with unique identifiers (UDIs). The proposed change would clarify the definition of convenience kit, reducing the number of accepted exemptions an... Read more »

Medical Tracking Solutions Partners with Summit Corporate Services

by BONEZONE | Dec 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Flex Acquires Farm Design, Expands Medical Design Capabilities

by BONEZONE | Dec 2015

Flex acquired Farm Design, an ISO 13485 Certified and FDA compliant product development company serving medical device and diagnostic companies.... Read more »

UDI Ruled a Requirement for EHRs

by BONEZONE | Dec 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices

by BONEZONE | Jul 2015

FDA’s most recent UDI draft guidance, Unique Device Identification: Direct Marking of Devices, addresses common questions posed by labelers preparing for the September 24, 2015 compliance deadline.... Read more »

FDA Launches Searchable UDI Database

by BONEZONE | Jun 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

CDRH Proposes Nationwide Postmarket Surveillance System

by BONEZONE | Apr 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

CAPA+2, UDI and More: What to Expect from FDA in 2015

by Hannah Corcoran | Feb 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Publishes Priorities for 2015

by BONEZONE | Jan 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

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 »

FDA Extends UDI Compliance Date for Certain Orthopaedic Implants

by BONEZONE | Dec 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

GHX Successfully Submits Product Data to the FDA Production Global UDI Database (GUDID) Ahead of Deadline

by BONEZONE | Sep 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Publishes Q&A on UDIs

by BONEZONE | Sep 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

UDI Implementation: What are Your Next Steps?

by Jonathan Bretz | Jun 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

GHX Announces UDI Solution

by BONEZONE | Jan 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Finalizes UDI Requirements

by BONEZONE | Sep 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Announces Final Rule for Unique Device Identification System

by BONEZONE | Sep 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

VeriTeQ’s Technology Can Help Manufacturers Comply with FDA Proposed Rule on Direct Mark Requirement for UDI

by BONEZONE | Jul 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

UDI Update: Prepping for the Final Ruling

by Karen Conway | Jul 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

BONEZONE Authors Present Solutions at OMTEC 2013

by BONEZONE | Apr 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

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

by BONEZONE | 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 BONEZONE | 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 »