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Adroit Medical Systems Certification Adroit Medical Systems, Inc., a leading manufacturer of thermoregulation and temperature therapy products, announced today that the Company's management system has been certified to ISO 13485:2003. ISO 13485 is the international quality management standard for designers and manufacturers of medical devices and related services, and is harmonized with the U.S. FDA's good manufacturing practices. Adroit Medical has actively pursued this certification as part of an ongoing commitment to achieve compliance with regulatory requirements in response to the needs of the medical community at a global level. The Company had previously been certified to ISO 9001:2000 and will maintain that standard for broader coverage of international regulatory requirements. "Adroit Medical has always been committed to providing the highest levels of service excellence," according to Kelley Patten, Operations Quality Manager. "Achieving ISO 13485 demonstrates that our focus is on quality." "This certification is the direct result of the hard work by the entire Adroit Medical Systems team. Our employees understand this standard helps us meet customer and regulatory requirements in the U.S. and in other countries," added Greg Jones, Project Manager, Adroit Medical Systems. About Adroit: Adroit Medical Systems is a manufacturer, developer, and marketer of conductive and convective thermal regulation systems. Adroit Medical serves all patient care settings from hospital to homecare. The company offers multiple ways of heating and cooling the human body for surgical procedures or improving neurological recovery of the seriously injured. The Company also makes localized temperature therapy products for athletic cooling and musculoskeletal pain relief. Adroit Medical Systems is a technology partner of MTRE Advanced Technologies, Ltd. |
Adroit Medical Systems 1146 Carding Machine Rd Loudon, TN 37774 USA Tel: 800-267-6077 © 2006-08 Adroit Medical Systems All Rights Reserved Site by Web Templates Gallery |
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Adroit Medical Systems manufactures disposable medical devices and durable medical equipment. We offer heat therapy, cold therapy, temperature regulation and therapeutic hypothermia systems. Adroit Medical Systems is also a contract manufacturer specializing in development and production of thin film and non-woven disposables such as sterile draping and surgical instrument covers. Brands include; HTP-1500 heat therapy, Mobile ICE cold therapy, Soft-Temp patient warming, MTRE therapeutic hypothermia, Wrapid Pass sterile wrap. OEM brands: Mistral-Air, Cool-Shirt. Registrations: ISO 13485:2003. ISO 9001-2000, FDA, Medicare DME. |