
Cardiocom™ Multi-Disease Management Receives Quality System Certification
to ISO 13485:2003
PR Newswire
MINNEAPOLIS
– CardiocomŽ Multi-Disease Management, a leader in developing and
manufacturing home telemonitoring equipment and chronic disease
management software, today announced that it has achieved ISO
13485:2003 medical device certification from BSI Management Systems.
Cardiocom launched its products in Europe earlier this year and plans
to provide telemonitoring systems in Canada in 2008.
ISO
13485:2003 is an internationally recognized Medical Device Quality
Management System (QMS) standard developed by the International
Organization for Standardization (ISO). To be certified to the
standard, companies must implement a Medical Device QMS ensuring steps
to identify, manage and minimize the risks involved with the design and
manufacture of medical devices. Certification to ISO 13485:2003
reinforces to customers, through an independent third-party, that
Cardiocom operates their Medical Device QMS in accordance with their
standard.
Certification under the ISO standard was
granted to Cardiocom in recognition of their superior compliance with
requirements for implementation of comprehensive quality management
systems. These systems include the operational procedures used in the
design and manufacture of Cardiocom’s home telemonitoring products.
Cardiocom’s investment in training and continuous quality control,
enable the company to provide the highest quality remote home
monitoring solutions for patients with chronic disease.
"Our
success in achieving ISO 13485:2003 certification is due to the
outstanding dedication and teamwork of our employees who embrace our
quality processes" said Daniel L. Cosentino, President. " Our goal is
to continue to provide our customers with the highest quality products
and services expected of a major designer and manufacturer of
telemonitoring devices."
About Cardiocom
Cardiocom (www.cardiocom.com)
is an award-winning leader in innovative patient telemonitoring and
disease management solutions. Founded in 1997, Cardiocom develops,
manufactures and markets its own telehealth devices for congestive
heart failure, diabetes, hypertension, obesity, COPD, severe asthma,
and ESRD. GlucoCom™ (www.glucocom.com), a division of Cardiocom that
provides blood glucose monitoring products, was added to the product
line in 2006. Cardiocom’s clients include some of the most respected
health plans, hospitals, physician groups, home health groups and
disease management vendors in the nation. Through these established
relationships, Cardiocom improves the lives of thousands of people each
day.
Contact
Cardiocom
888-243-8881 or info@cardiocom.com
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