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  OsseoLink News

Global Implant Solutions, LLC Announces ISO 13485 Quality System Certification
June 12, 2009

Bedford, MA, USA. 
Global Implant Solutions, LLC (GIS) is pleased to announce a news item that will further enhance the commercialization of its OsseoLink Dental Implant System.
The company has successfully completed its ISO 13485 certification audit and has been awarded a final certificate.  ISO 13485 is a worldwide-recognized medical device quality system standard, and certification to this standard is a requirement for any medical device company to develop, manufacture, and market products in Europe, Canada, and other markets.  The quality system was audited by BSI Management Systems America Inc., one of the foremost auditing bodies in the world.

The company has also been scheduled to for review of the OsseoLink Dental Implant System for CE Mark certificate in accordance with Annex V of the Medical Device Directive 93/42/EEC, with BSI acting as the Notified Body and issuing the certificate.  Achieving the CE Mark allows GIS to market the OsseoLink Dental Implant System  directly to the 27 countries within the European Union plus the additional 4 countries that recognize the CE Mark.  This market is comprised of approximately 400M people.  The dental implant market in Europe represents approximately 40% of the worldwide implant market, and is thus a significant market for GIS and its OsseoLink system. 
“We are very pleased to have achieved ISO 13485 certification,” states Scott Johnson, Director of International Sales of GIS.  “We are committed to producing high quality products and services for our distributors and customers.  ISO 13485 certification is the first step toward attaining CE Mark which will allow us to approach European distribution partners with regulatory approval already in hand.  This will facilitate more timely access to a very large and progressive dental implant market.  In addition the combination of ISO certification and CE Mark opens the door to other non-EU markets.”  

About Global Implant Solutions, LLC
Global Implant Solutions (GIS), LLC, was incorporated in the state of Delaware, and now boasts offices in Boston, the intellectual center of the United States. Moreover, our manufacturing is conducted in Michigan, home to world-renowned engineers and manufacturing facilities.

GIS emerged from the knowledge and excellence of academicians and clinicians with a diverse background with the ambition of uniting creativity, simplicity, and versatility into a single device.

The corporate structure of GIS facilitates the free-flow of information between its varying experts, allowing engineering precision to harmonize with clinical creativity and excellence. The end result is the production of a fresh, innovative approach to implant dentistry that provides solutions to dilemmas that have challenged the industry for years.

Our dedication to implant dentistry is our motivation, and we place a strong focus on research and development. We are confident that this determination coupled with our business model will lead our company and the industry as a whole towards a brighter future.
 

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