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| Establishment Labs Announces the Certification of ISO 13485 and ISO 9001 by the British Standards Institute (BSI) |
The worldwide regulatory framework for implantable medical devices and breast implants in particular is being strengthened by new legislation and rules. At Establishment Labs, as part of our process of continuous improvement, we began a process to re-certify our Quality System with the most prestigious certification company worldwide. ISO 13485, published in 2003, and now fully recognized in many countries, is based on the ISO 9001 process model approach. These standards provide a good base model, recognized by the Global Harmonization Task Force (GHTF), for compliance with the European Union (EU) CE marking medical device directives, Health Canada CMDCAS, Taiwan Medical Device Regulations, Japan JPAL and the FDA.
Certification to ISO 13485 takes place when an accredited third party, such as BSI, visits an organization, assesses the quality management system and, if satisfactory, issues a certificate confirming that the organization’s quality management system meets the requirements of the standard. BSI quality management systems certificate is objective, accredited, and recognized evidence of our company’s commitment to quality systems and helps us demonstrate this to customers and regulators.
Plastic Surgeons and patients worldwide are demanding the strictest controls for breast implants and at Establishment Labs we take this challenge and make it into a reality.
For more information visit: www.bsigroup.com.
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| Establishment Labs Publishes the Results at 2 Years of its Breast Implant Study |
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The 2-year results are now available of the Prospective 10 years follow-up clinical evaluation which is being conducted to confirm the safety and efficacy of Motiva Implant Matrix® Silicone Breast Implants in 85 patients. Over the course of the year the study will be extended to 215 augmentation and revision patients. The study relates to round SilkSurface™, SilkSurface Plus™, VelvetSurface™ and VelvetSuface Plus™ families of round silicone implants manufactured by Establishment Labs.
The results of the study have confirmed again the safety and efficacy of Motiva Implant Matrix® and the high levels of satisfaction of both plastic surgeons and patients as well as a very low incidence of capsular contracture. Establishment Labs publishes every quarter a Worldwide Complaint Report Summary that shows a very similar trend for Motiva Implant Matrix®.
To request electronic copies of the study write to: customerservice@establishmentlabs.com
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| Establishment Labs Presents Breast Implant with UDI at the World Congress of Plastic Surgery |
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Establishment Labs participated as Bronze Sponsor of the World Congress of Plastic Surgery (IPRAS) that took place in Santigo, Chile at the end of February. Located in the main exhibition area, the Motiva Implant Matrix® stand was one of the main attractions as plastic surgeons queued to see the world première of a silicone breast implant with an imbedded Unique Device Identificator (UDI) micro-transponder.
Developed in conjunction with VeriteQ, this FDA approved technology is the latest in a stream of innovations coming to market from Establishment Labs. The technology is expected to hit the European market before the end of the year. Randy Geissler, President of VeriteQ, attended the meeting to meet plastic surgeons and discussed their views of this exciting technology. The local Motiva Implant Matrix® distributor, Alexandra von Koeller, deserves special praise for her team´s professionalism and hospitality.
For more information about this congress visit: www.ipraschile.cl
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| The PIP Patient Support Program comes to an End |
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Establishment Labs created a special assistance program to assist patients with faulty PIP implants. Having given support for the last 2 years to hundreds of plastic surgeons in various continents to solve the problems of thousands of patients, the PIP Patient Support Program has come to an end.
This special program was chosen by the Social Security System of Costa Rica to exchange PIP implants in hundreds of breast reconstruction patients. Hungary and Columbia were at the top of the list in this program for breast augmentation patients. The program received special press coverage in print, TV and radio in many countries, reinforcing the scientific brand image of Motiva Implant Matrix®.
The program officially ended on June 1st 2013, giving plastic surgeons the opportunity to handle the required documentation for the replacements until July 15th 2013.
For more information contact customerservice@establishmentlabs.com.
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| Establishment Labs, a Main Sponsor at TransAlp Plastic Surgical Meeting |
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This innovative congress took place in early May at the beautiful Italian town of Brixen, in the southern Tyrol, with the participation of the plastic surgery societies of Austria, Italy and Switzerland and in collaboration with the University of Padua.
Motiva Implant Matrix® had an important place in the scientific program with a detailed lecture by renowned Professor Dr. Georg Huemer from Linz, Austria. In these times of congress overload, this scientific meeting has drawn a growing crowd of younger dynamic plastic surgeons. And by the way, this congress does not ask for a registration fee from the attending plastic surgeons!
For more information visit: TransAlp Plastic Surgical Meeting. |
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