Salt Lake City, UT, August 12, 2010 -- JTECH Medical, a medical device company developing innovative, next-generation therapeutic and evaluation products, announces that it has received certification to ISO 13485:2003 by Intertek Testing Services NA Ltd., a Health Canada recognized registrar. JTECH received certification to ISO 13485:2003 and ISO 9001 in 2008 but sought to expand opportunities for users and patients in Canada which required certification by a Health Canada recognized registrar. JTECH also applied for, and received, a Device Establishment License to distribute our products throughout Canada.
Commenting on the announcement, Len Smith, President of JTECH Medical, said, "Achieving CMDCAS certification is a further endorsement of JTECH's manufacturing capabilities and approach to quality system management. This has enabled us to move forward with the registration and commercialization of our products in Canada. We plan to aggressively promote and market our products in Canada immediately."
In addition to ISO 13485:2003, JTECH Medical also renewed its ISO 9001:2008 certification demonstrating that JTECH Medical is continually looking to improve our quality management system in order to meet our clients' and regulatory agencies' expectations. The transition to the 2008 version of the standard was first completed in 2009.
JTECH Receives Notification from Health Canada Regarding Device Classification
Salt Lake City, UT, August 12, 2010 -- JTECH Medical received notification from Health Canada that our products are considered to be Class I devices in Canada. JTECH Medical has already received an Establishment License from Health Canada and therefore our products are cleared for sale in Canada.
JTECH Medical has grown to become a recognized world leader in physical evaluation and functional testing products. Our growth and continued success is based on three key elements: our ability to cost-effectively adapt new and emerging technologies to the field of physical medicine, our commitment to manufacturing high-quality and reliable products, and our dedication to providing superior customer service and support.
Leading through technological innovation has always been a directive at JTECH Medical. We developed and patented the world's first digital dual inclinometer for measuring spine and extremity range of motion.
Before computers were standard in every medical practice, we introduced the first generation of our Tracker computerized functional testing system. Most recently, we developed a miniature radio frequency transceiver to eliminate the cords so testing with Tracker instruments is faster and easier.
As JTECH has grown, so has our commitment to supporting our customers. Today, we have an education department focused on presenting classes and seminars that help you grow your practice through greater efficiency and new services like functional capacity evaluations (FCE). We also have one of the largest, best staffed customer service departments in the industry armed with tools like easy access to our computer programmers, engineering staff and a host of practicing clinicians to get you get the right answer.
Moving into the future is exciting at JTECH Medical. We are continually exploring to find new technologies and new ways of applying them in ways that help our customers become more efficient, productive and successful.
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