MINNEAPOLIS, Nov. 06 /CNW/ -- Cardiocom(R) 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 LLC
Cardiocom (http://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(TM) (http://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.
Jodie Root, Vice President, Sales & Marketing, Cardiocom
888-243-8881 or email@example.com
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