Pioneering sophisticated technologies for
sleep disorders &
movement disorders
to improve the quality of life for people around the world.
1.877.CLEVEMED (1.877.253.8363)
1.877.CLEVEMED (1.877.253.8363)
CleveMed News Releases
For More Information Contact:
Amy RickardCleveland Medical Devices Inc.
Phone: 216.791.6720
arickard@clevemed.com
www.CleveMed.com
FOR IMMEDIATE RELEASE
CLEVEMED RECEIVES ISO 13485:2003, CMDCAS and MDD 93/42/EEC CERTIFICATIONS
CLEVELAND, OHIO, October 27, 2009 – CleveMed recently had its Quality Management System certified to the requirements of ISO 13485:2003 and the Canadian Medical Device Conformity Assessment System by BSI, one of the world′s leading certification bodies. BSI also certified CleveMed to European Medical Device Directive 93/42/EEC which is required to place the CE mark on its products. These certifications allow CleveMed to distribute its products to the large European and the Canadian markets and strengthen its worldwide market presence.
CleveMed designs, manufactures, and sells a number of telemetry-based patient monitors for sleep disorders such as sleep apnea and movement disorders including Parkinson′s disease. Accuracy, portability and ease-of-use allow CleveMed′s products to be uniquely suited to speed diagnosis and improve disease management of these disorders in emerging US and international markets. These non-traditional, growing markets include the home, hospital rooms, private practices, and many others. As a leader in miniaturized wireless telemetry, physiological monitors CleveMed has been successfully commercializing a research and education product line that will benefit tremendously from international markets as well.
"CleveMed undertook the rigorous medical device certification as part of its commitment to developing products with the highest quality that fulfill un-met clinical needs for patients and providers" stated Hani Kayyali, President of CleveMed. "It is a testament to our continued growth and excellence in these important medical fields."
Robert N. Schmidt, Chairman and CEO of CleveMed stated "This is an important milestone for the company. Opening up new markets for us in Europe and around the world will allow us to double our commercial sales over the next year or two."
About CleveMed
CleveMed is pioneering the use of novel wireless monitoring systems for high growth neurology and rehabilitation applications. Through these innovations, CleveMed has developed a growing range of products that address the needs of the medical, research and academic communities around the world. Cleveland Medical Devices Inc.′s mission is to develop, manufacture and market rehabilitation and monitoring products that improve quality of life and allow patients to leave the hospital earlier, thus lowering total health care costs. For more information, please visit www.CleveMed.com
