CleveMed recently received ISO 13485 certification issued by BSI Management Systems America Inc., one of the foremost auditing bodies in the world. CleveMed has also received the CE Mark and CMDCAS allowing its products to be distributed to the large European and the Canadian markets which will strengthen its worldwide market presence.
CleveMed designs and manufactures 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 monitoring and rehabilitation devices CleveMed has been successfully commercializing a research and education product line that is expected to 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.”
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