Objet Geometries Gains ISO 13485:2003 for Medical Devices Certification
By Objet Geometries Ltd., PRNEMonday, September 27, 2010
REHOVOT, Israel, September 28, 2010 - Objet Geometries Ltd. (www.objet.com/), the innovation leader of
3D printing for rapid prototyping and additive manufacturing, announced today
that it has achieved the ISO13485:2003 certification for medical devices. ISO
13485 specifies requirements for a comprehensive quality management system
for the design and development, production, installation and servicing of
medical devices. This international standard confirms Objet's ability to
provide the medical industry with 3D printers and related services that meet
the regulatory requirements applicable to medical devices.
Logo: www.newscom.com/cgi-bin/prnh/20080514/305187
"We are very pleased to achieve this ISO certification, which is a
further reinforcement of the quality of our 3D printing systems for the
medical and dental arenas," says Gilad Gans, Executive Vice President at
Objet Geometries. "We are very committed to the medical industry and to
meeting our medical and dental customers' expectations while adhering to
strict regulatory compliance regulations. This ISO 13485 medical
certification validates our consistent obligation to high-quality 3D printing
systems and processes and provides independent confirmation that our Quality
Management System (QMS) is in full compliance with industry and regulatory
standards," added Gans.
Avi Cohen, Head of Medical Solutions at Objet Geometries, added:
"ISO13485 has become the standard against which medical device suppliers are
measured to drive quality within the medical and dental market. The addition
of ISO13485 complements our existing ISO standards. The medical and dental
industry is a major strategic focus for Objet Geometries and this
certification represents an important milestone, further supporting our
vision to be recognized for 3D printing solutions for the ongoing
manufacturing of commercial medical and dental devices."
About Objet Geometries
Objet Geometries Ltd. (www.objet.com/), the innovation leader in
3D printing for rapid prototyping and additive manufacturing, provides
3-dimensional printing systems that enable manufacturers and industrial
designers to reduce cost of product development and dramatically shorten
time-to-market of new products.
Objet's ultra-thin-layer, high-resolution 3-dimensional printing systems
and materials utilize PolyJet polymer jetting technology, to print ultra-thin
16-micron layers. The market-proven Eden line of 3D Printing Systems and the
Alaris30 3D desktop printer are based on Objet's patented office-friendly
PolyJet Technology. The Connex multi-material family is based on Objet's
PolyJet Matrix Technology, which jets multiple model materials simultaneously
and creates composite Digital Materials on the fly. All Objet systems use
Objet's FullCure(R) materials to create accurate, clean, smooth, and highly
detailed 3D parts.
Objet systems are in use by customers worldwide, including Fortune 100
companies, in multiple industries such as Education, Medical / Medical
Devices & Dental, Consumer Electronics, Automotive, toys, consumer goods, and
footwear industries.
Founded in 1998, Objet serves its growing global customer base through
offices in USA, Mexico, Europe, Japan, China and Hong Kong, and a global
network of distribution partners. Objet owns more than 50 patents and patent
pending inventions. For more information, visit us at www.objet.com.
(c) 2010 Objet, Quadra, QuadraTempo, PolyJet, FullCure, SHR, Eden,
Eden250, Eden260, Eden 260V, Eden330, Eden350, Eden350V, Eden500V, Job
Manager, Objet Studio, CADMatrix, Connex, Connex350, Connex500, Alaris,
Alaris30, PolyLog, TangoBlack, TangoGray, TangoPlus, TangoBlackPlus,
VeroBlue, VeroWhite, VeroBlack, VeroGray, Durus, Digital Materials, Polyjet
Matrix and ObjetGreen are trademarks or registered trademarks of Objet
Geometries Ltd. and may be registered in certain jurisdictions. All other
trademarks belong to their respective owners.
Objet Media Contacts USA Robyn Stein or Sharon Horowitz Gabbegroup Tel. +1-212-220-4444 Email. robyn.stein@gagge.com / Sharon.horowitz@gabbe.com UK Dave Chandler UK Bespoke Tel: +44-1737-215200 E-mail. davec@bespoke.co.uk Objet Arita Mattsoff Objet Geometries Tel. +972-8-931-4314 Email. arita@objet.com Asia Pacific Jenny Chan The Hoffman Agency Tel: +81-3-2231-8101 Email. jchan@hoffman.com Japan Masaya Takahama The Hoffman Agency, Japan Tel: +81-3-5159-2145 Email. mtakahama@hoffman.com China Dong Chen The Hoffman Agency, China Tel. +86-21-6391-5869 Email. dchen@hoffman.com
Objet Media Contacts: USA: Robyn Stein or Sharon Horowitz, Gabbegroup, Tel. +1-212-220-4444, Email. robyn.stein at gagge.com / Sharon.horowitz at gabbe.com ; UK: Dave Chandler, UK Bespoke, Tel: +44-1737-215200, E-mail. davec at bespoke.co.uk ; Objet: Arita Mattsoff, Objet Geometries, Tel. +972-8-931-4314, Email. arita at objet.com ; Asia Pacific: Jenny Chan, The Hoffman Agency, Tel: +81-3-2231-8101, Email. jchan at hoffman.com ; Japan: Masaya Takahama, The Hoffman Agency, Japan, Tel: +81-3-5159-2145, Email. mtakahama at hoffman.com ; China: Dong Chen, The Hoffman Agency, China, Tel. +86-21-6391-5869, Email. dchen at hoffman.com .
Tags: Israel, Objet Geometries Ltd., Rehovot, September 28