MINNEAPOLIS, Feb. 3 /PRNewswire/ -- Arobella Medical, LLC, today announced the achievement of ISO 13485:2003 certification for the design, development, manufacturing, test, and delivery of medical devices. This certification, developed by the International Organization for Standardization (ISO), is the regulatory standard for the international medical industry and is closely related to ISO 9000 and EN 46000. Receiving the certification proves that the design, development and manufacturing functions at Arobella Medical meet the highest quality internationally recognized standards known for medical devices. Arobella Medical was assessed and registered by Intertek Testing Services NA Ltd.
Arobella Medical produces the Qoustic Wound Therapy System(TM), an FDA-cleared wound therapy device that applies low-frequency, cavitational ultrasound to gently remove dead and diseased tissue cells, kill harmful bacteria and biofilm, and leave healthy and pre-healing granulation tissue intact. Already on sale in the United States, ISO 13485 certification brings the device one step closer to a wider international marketplace. ISO 13485 is a regulatory requirement in a number of international markets for the manufacture of medical devices, including Europe, Canada, Taiwan and Australia, and forms the cornerstone for the CE certification of medical products in the EU.
“This certification demonstrates our continued commitment to developing the finest, cutting-edge ultrasound medical devices on the market,” said Eliaz Babaev, PhD, president and CEO of Arobella Medical. “We continually strive to be the best in ultrasound, and have the data to prove it. We will use this achievement to bring our products to the rest of the world.”
About Arobella Medical, LLC
Arobella Medical, LLC is Minneapolis-based medical device company specializing in low-frequency ultrasound in wound management therapies. Arobella Medical, LLC is positioned to become the leader in advanced ultrasound wound care technologies and devices. Arobella Medical, LLC co-founder and CEO Eliaz Babaev has more than 45 years of experience developing, designing and commercializing medical devices that use ultrasound. For more information, go to http://www.arobella.com.
CONTACT: Glenn Carlson, Business Affairs Manager of Arobella Medical, LLC,
+1-612-288-2826, gcarlson@arobella.com
Web site: http://www.arobella.com/
