Digirad Achieves Certification to the Latest ISO Quality Management System Standards for Medical Device Manufacturers
January 27 2006 - 11:30AM
Business Wire
Digirad Corporation (NASDAQ:DRAD), a leading provider of
cardiovascular imaging services and solid-state nuclear medicine
imaging products to physician offices, hospitals and imaging
centers, announced today that it has been awarded certification to
the most recent International Standard Organization (ISO) standard
for medical device manufacturer Quality Management System
requirements, ISO 13485:2003. This international standard specifies
requirements for a quality management system that can be used by an
organization for the design and development, production,
installation and servicing of medical devices, and the design,
development, and provision of related services. It can also be used
by internal and external parties, including certification bodies,
to assess the organization's ability to meet customer and
regulatory requirements. The certification also covers
Canadian-specific requirements for CMDCAS (Canadian Medical Devices
Conformity Assessment System), which is required to distribute
medical devices in that country. "We are pleased to have earned
certification to the current ISO 'gold standard' for quality
management systems," said Peter Sullivan, President of Digirad's
product business. "I congratulate our entire team on achieving this
rigorous certification. Their successful effort underscores
Digirad's commitment to excellence in every aspect of our
operations." About ISO ISO is a network of the national standards
institutes of 156 countries, on the basis of one member per
country, with a Central Secretariat in Geneva, Switzerland, that
coordinates the system. About Digirad Digirad Corporation develops,
manufactures and markets solid-state, digital gamma cameras to
hospitals, imaging centers and physician offices. Digirad offers a
comprehensive line of solid-state nuclear gamma cameras that
produce a high-quality image for use in the detection of many
medical conditions, including cardiovascular disease. Digirad's
cameras are unique as their lightweight and compact design allows
them to fit easily into small office spaces. Digirad's wholly owned
subsidiaries Digirad Imaging Solutions and Digirad Imaging Systems
offer a comprehensive and mobile imaging leasing and services
program for physicians who wish to perform in-office nuclear
cardiology procedures but do not have the patient volume, capital
or resources to justify purchasing a gamma camera. For more
information, please visit www.digirad.com. Digirad(R) is a
registered trademark of Digirad Corporation. Forward-Looking
Statements Digirad cautions that statements included in this press
release that are not a description of historical facts are
forward-looking statements. You can identify these statements by
the fact that they do not relate strictly to historical or current
facts and use words such as "anticipate," "estimate," "expect,"
"project," "intend," "plan," "believe" and other words and terms of
similar meaning in connection with a discussion of future operating
or financial performance or events. Examples of such statements
include the statements regarding Digirad's ability to meet customer
and regulatory requirements, Digirad's commitment to excellence,
and Digirad's ability to design, develop, produce, install and
service medical devices and related services. The inclusion of
these and other forward-looking statements should not be regarded
as a representation by Digirad that any of its plans will be
achieved. Actual results may differ materially from those set forth
in this press release due to the risks and uncertainties inherent
in Digirad's business including, without limitation: the degree to
which personnel changes and related disruptions in our business
activities may affect Digirad's products, customers, work force,
suppliers, and our overall business prospects and operations; the
degree to which Digirad's camera systems and related services will
be accepted by physicians and hospitals some of whom may experience
reliability issues or technical problems; the ability of Digirad to
effectively market, sell and distribute its medical devices, and
related services given its limited capabilities in these areas;
Digirad's ability to manage risks relating to product liability,
warranty claims, recalls, property damage and personal injury with
respect to its imaging systems; and other risks detailed in
Digirad's Securities and Exchange Commission filings, including its
Annual Report on Form 10-K and other reports filed with the
Securities and Exchange Commission. Given these uncertainties,
readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
All forward-looking statements are qualified in their entirety by
this cautionary statement and Digirad undertakes no obligation to
revise or update this press release including the forward-looking
statements contained herein to reflect events or circumstances
after the date hereof or to update the reasons actual results could
differ materially from those anticipated in these forward-looking
statements, even if new information becomes available in the
future.
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