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Articles Tagged "ex-US"

Concept Laser, GE Break Ground on 3D Printing Campus

by BONEZONE | Dec 2017

The Lichtenfels, Germany facility will house around 500 employees and will open in early 2019.... Read more »

Teleflex Medical OEM Announces New Suture Technology

by BONEZONE | Nov 2017

This may reduce tissue strangulation in applications where tissue pull-through may be a concern.... Read more »

China: Do You Need to Revamp Your Customer Channel?

An effective and efficient pathway to customers is important everywhere in orthopaedics, but perhaps nowhere is it more critical and complex than in China. ... 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 »

Quebec: Orthopaedic Innovation Hub

by BONEZONE | Oct 2017

The Canadian province of Quebec is home to a robust orthopaedic industry characterized by innovation, research, a history of achievement, manufacturing prowess and investment.... Read more »

In’Tech Medical Unveils New Brand

by BONEZONE | Sep 2017

The new branding is intended to showcase In'Tech's position as a global manufacturer of surgical instruments and implants.   ... Read more »

Eurocoating Medical Technology Holds Grand Opening Ceremony for China Facility

by BONEZONE | Sep 2017

  The Unitedcoatings Group announced the grand opening ceremony of Eurocoating Medical Technology (Wuxi) Co., LTD, established in China, in Xishan Economic & Technological Development Zone in October. ... Read more »

Tegra Medical Adds Manufacturing Space in U.S. and Costa Rica

by BONEZONE | Sep 2017

Tegra Medical is responding to customer needs and demand for a strong ex-U.S. presence.... Read more »

AP&C Opens Powder Manufacturing Facility in Quebec

by BONEZONE | Sep 2017

The new manufacturing plant in Saint-Eustache will employe 106 staff by the end of 2017.    ... Read more »

Proxy Biomedical Rebrands as Aran Biomedical

by BONEZONE | Apr 2017

The company seeks to leverage new facilities and an advanced technology portfolio to serve orthopaedic and other industries.   ... Read more »

Ideagen Acquired IPI Solutions

by BONEZONE | Mar 2017

IPI Solutions is the developer of the Visual software platform for quality and compliance reporting.   ... Read more »

United Performance Metals Opens Facility in Budapest, Hungary

by BONEZONE | Feb 2017

The facility is the company’s 3rd location ex-U.S. and covers specialty metals distribution, sales and processing.... Read more »

China’s Medtech Policy Sets Path for Orthopaedic Manufacturers

by BONEZONE | Feb 2017

The Chinese government has prioritized medical device development, as well as local and international investments by domestic device companies. These initiatives, along with shifts in OEM to hospital distribution channels and newly-structured tiered healthcare, are expected to affect and shape the o... Read more »

In'Tech Medical Reports 2016 Revenue

by BONEZONE | Feb 2017

In'Tech Medical reported 2016 global revenue of US $61.0MM, -1.6% from 2015 revenue of $62.0MM.... Read more »

Amplitude Surgical Acquires 50% Stake in SOFAB Orthopedie

by BONEZONE | Dec 2016

SOFAB's capabilities range from machining to polishing and engraving.... Read more »

Autocam Medical Suzhou, China Facility Registered to ISO 13485

by BONEZONE | Dec 2016

Initial registration is to ISO 13485:2003, but upgrade to ISO 13485:2016 expected by next surveillance audit.... Read more »

Tegra Medical Acquired by SFS Group

by BONEZONE | Nov 2016

Switzerland-based SFS provides customized precision-formed components and mechanical fastening systems. ... Read more »

GE to Acquire Stake in Concept Laser

by BONEZONE | Oct 2016

GE will acquire a 75% stake in Concept Laser, manufacturer of additive manufacturing machines.... Read more »

Boston Centerless Appoints HnG Medical as Exclusive Sales Agent in China

by BONEZONE | Aug 2016

The exclusive sales relationship will serve the People’s Republic of China, the Republic of China/Taiwan, Vietnam, Singapore, Malaysia and Korea.... Read more »

Nelipak Acquires Tegrant Alloyd Brands, a Medical Thermoformer

by BONEZONE | Jul 2016

Nelipak acquired Tegrant Alloyd Brands, manufacturer of thermoformed rigid packaging for medical markets, including orthopaedics.... Read more »

Precision Coating Establishes Costa Rica Operations

by BONEZONE | Jul 2016

Precision Coating (PCCI) is establishing operations in Costa Rica, with a new plant to be operational by the end of July 2016.... Read more »

Proxy Biomedical Announces Facility Expansion

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 »

Orchid Completes Acquisition of Cam Bioceramics Coating Facility in China

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 »

Teleflex Medical OEM Introduces Force Fiber OrthoTape Braid

by BONEZONE | Dec 2015

Teleflex Medical OEM has launched Force Fiber® OrthoTape™ Braid, an ultra-strong/ultra-thin tape, to its suture product line, and received a Hong Kong Patent for Force Fiber® Suture.... Read more »

Manufacturing or Selling Medical Devices in Mexico: A Regulatory Conundrum

by John Gagliardi | Oct 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 »

Brazil Remains Among Top Ten Markets, Despite Economic Downturn

by Hannah Corcoran | Oct 2015

Claiming the 7th largest economy in the world and the largest in South America, Brazil is a force in the global medical device market.... Read more »

International and Domestic Manufacturers Compete to Serve Growing Asian Population

by Ames Gross | Oct 2015

Orthopaedics remains an attractive and growing market, especially in Asia. Multiple factors contribute to the growth of the orthopaedic market in this region.... Read more »

FDA Outlines Stance on ex-U.S. Clinical Data

by Hannah Corcoran | 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 »

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 »

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 »

Japan: Entering an Established Market

by BONEZONE | Dec 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 »

A Supplier’s View on the Indian Market

by BONEZONE | Dec 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 »

National Joint Registry for England, Wales and Northern Ireland: Findings from 10th Annual Report

by BONEZONE | Dec 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 »

Looking Ahead to 2014

by BONEZONE | Dec 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 »

India Considering New Device Regulations

by John Gagliardi | Aug 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 »

Spotlight on Asia

by BONEZONE | Aug 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 »

Spotlight on Europe

by BONEZONE | May 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 »

The Basics: A Look at the French Medical Device Market

by BONEZONE | May 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 »

Conquering the German Market in Six Months

by Stefan Pickartz | May 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 »

Three Reasons Ireland’s Orthopaedic Sector Attracts Foreign Investments

by Brian Thornes, M.D. | 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 »

Spotlight on Argentina

by BONEZONE | Feb 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 »

Entering the Market in Argentina

by BONEZONE | Feb 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 »

Passing Brazil’s Inspections to Take Product to Market

by John Gagliardi | Jan 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 »

Spotlight on Brazil

by BONEZONE | Jan 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 »

The Global Orthopaedic Supplier Market

by Julie A. Vetalice | Dec 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 »