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Articles Tagged "MDR"

EU MDR: How to Respond to Today’s Knowns and Unknowns

by Carolyn LaWell | Apr 2019

Orthopedic device companies implementing EU MDR should consider these eight actions, while thinking strategically about the unknowns of the regulation.   ... Read more »

EU MDR Implementation: Are you prepared?

by bsi | Mar 2019

EU MDR planning is a classic project management activity to identify what has to be done, in what order, by whom and by when, and how progress will be monitored. Every project will vary...it's not possible to create one implementation plan applicable to all organizations. This paper offers guidance... Read more »

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 »

Supply Chain Quality Panel, Part II: OEM and Supplier Perspectives

by BONEZONE | Jul 2018

In this installment, supply chain experts from Autocam Medical, MicroPort Orthopedics, Orchid Orthopedic Solutions and Zimmer Biomet discuss challenges associated with EU MDR, third-party audits and the need for more consistency across industry.... Read more »

Your EU Medical Device Regulation Guide

by BONEZONE | Oct 2017

Big changes are underway for the European market and how it regulates medical devices with the recent unveiling of the Medical Device Regulation MDR 2017/745.... Read more »

Once an Easy Path, Europe’s Regulatory Approval Toughens

by BONEZONE | Mar 2017

Enactment of the EU's Medical Device Regulations is expected to increase challenges for orthopaedic companies seeking CE Mark Approval.... 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 »

ZL Engineering Plastics Opens New Extrusion Facility

by BONEZONE | Sep 2012

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 »

The Anatomy of a Warning Letter, Part One: A Primer

by John Gagliardi | Mar 2012

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 »