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Press Releases
ARIBEX Announces ISO Certifications and CE Mark Approval for
NOMAD Portable X-ray Systems
OREM, UTAH–16 November 2006–ARIBEX, Inc., a leader in portable
handheld x-ray products, today announced that it has been certified
to the ISO 9001:2000 and ISO 13485:2003 CMDCAS standards for
its operations. ARIBEX also announced the CE Marking approval
for the NOMAD Dental and NOMAD Dental CE portable handheld x-ray
systems, allowing their distribution in the European Union and
other countries that recognize the CE Mark.
The ISO 9001 and ISO 13485 standards are recognized worldwide
as international standards that define quality management practices.
In order to obtain these certifications, ARIBEX implemented an
extensive quality system that included document controls, product
and manufacturing processes, and a management and training program
aimed at developing safe and consistent products for the medical
device industry.
“Certification to the ISO Standards demonstrates ARIBEX’s ongoing
commitment to providing the highest quality products,” said Dr.
D. Clark Turner, president and chief executive officer of ARIBEX,
Inc. “These high standards result in safe and consistent products
and greater customer satisfaction.”
“ARIBEX has taken another major step forward to make radiography
easier, more convenient, and more accessible,” said Douglas Harding,
quality and regulatory manager at ARIBEX. “By receiving CE Marking
approval for NOMAD, the European Union will begin to benefit
from NOMAD’s ability to safely take quality dental x-ray images
with a truly portable handheld x-ray.”
ARIBEX was certified as meeting the requirements of ISO 9001:2000
for design, manufacture and service of portable x-ray equipment
by VDE Pruf- und Zertifizierungsinstitut of Offenbach, Germany
and by DQS Gmbh of Frankfurt, Germany for certification to the
ISO 13485:2003 CMDCAS standards. VDE also certified ARIBEX to
Annex II Section 3.2 of the EC Directive 93/42/ECC for medical
devices allowing CE Marking for the NOMAD Dental and NOMAD Dental
CE x-ray systems.
About ARIBEX
ARIBEX, Inc. has quickly become recognized as a worldwide leader
in innovative, portable / hand-held x-ray products. ARIBEX
is a privately owned, Orem, Utah-based company founded in 2003
with the mission to develop, manufacture, and market new technologies
in the x-ray radiography fields. ARIBEX’s flagship product
is the NOMAD Dental x-ray system. NOMAD Dental x-ray system.
NOMAD’s battery-powered handheld platform provides for expansion
from dentistry into other x-ray imaging solutions such as veterinary,
medical, industrial, and security applications. For more information,
visit www.aribex.com.
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Company Contact:
Richard Jackman
Marketing Manager
Aribex, Inc.
Phone: (801) 226-5522
www.aribex.com
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