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Articles Tagged "EU"

How the European Union's MDR Will Impact Your Company's Supply Chain

by BONEZONE | Aug 2018

OEMs must engage partners in conversations about the information needed from each party for Medical Device Regulation in order to meet regulatory requirements, timelines for CE Mark approval and make critical considerations for audits.... Read more »

Tegra Medical Expanding Sales to Europe

by BONEZONE | Jan 2018

The company has also named Mr. Neil Garner as European Business Development Manager... Read more »

A Watchful Eye on Device Performance can Decrease Postmarket Surveillance Burdens

by BONEZONE | Jan 2017

Our global industry requires companies to develop harmonized postmarket surveillance systems that minimize inconsistencies in our understanding of product lifecycle risks.... Read more »

3 Points to Consider from the Long-Awaited EU Medical Device Regulations

by BONEZONE | Jul 2016

The new EU Medical Device Regulations could make it tougher for orthopaedic device manufacturers to do business in Europe.... Read more »

CoorsTek Acquires Philips’ Ceramics Operation in the Netherlands

by BONEZONE | Jun 2016

CoorsTek has acquired Philips’ ceramics operations in Uden, The Netherlands. Through this acquisition, CoorsTek expands its strategic partnership with Philips and will serve both Philips and other regional customers from Uden. Adding Uden extends the CoorsTek footprint to a dozen European ma... Read more »

Orchid Announces Appointment of President and Chief Operating Officer, Jerry Jurkiewicz

by BONEZONE | Apr 2016

Orchid Orthopedic Solutions has named Jerry Jurkiewicz as President and Chief Operating Officer (COO) effective April 4, 2016. As President and COO, a new role for Orchid, Jurkiewicz will report directly to CEO Mike Miller and hold responsibility for managing global operations and directing the exe... Read more »

EU Proposes Significant Changes for Importers and Distributors

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 »

Preparation for Spinal Reclassification Under Way, Despite Pending EU Regulations

by Carolyn LaWell | Nov 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 »

Medical Education: A Look at the Future from a Device Perspective

by Stefan Pickartz | Apr 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 »

Start Early: Converting Your Spinal Technical File into a Class III Design Dossier

by Robert Packard | Dec 2013

As part of EU Commission regulatory changes, spinal implants will be reclassified from Class IIb devices to Class III devices. OEMs with spinal implants on the market should be proactive and start planning for reclassification now.... Read more »