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Integrity Life Sciences Receives CE Mark and ISO Certifications for the Integrity Spinal Care System Medical Device
Date:7/12/2012

nufacturers, such as Integrity Life Sciences. The ISO 13485:2003+AC:2009 (Medical Devices) accreditation certifies Integrity for the design, development and manufacturing of their Integrity Spinal Care System and confirms Integrity's compliance with this demanding quality standard. Mr. Gibson stated, "As a provider of medical products associated with the treatment of debilitating spinal disorders, and our recognized expertise in the medical device industry, we must not only meet the stringent regulatory requirements applicable to medical devices and their related services, because our name is Integrity, we must exceed them as well. "

Mr. Gibson concluded with the following thoughts, "Today, every medical device manufacturer strives to separate themselves from their perceived competitors. With the CE Mark and ISO Certification it opens the entire world as our marketplace." Mr. Gibson was also referencing the company's previous success, the FDA 510(k) clearance that was issued from the US FDA's, Division of Surgical, Orthopedic and Restorative Devices, Office of Device Evaluation, Center for Devices and Radiological Health. "The cumulative impact on Integrity as an organization is not only these prestigious certifications but when implemented properly into an organization, they can be strategic tools that reduce costs by minimizing waste and errors, while increasing productivity, quality and safety. In the end, Integrity wins and so does the doctor who uses our equipment with confidence, and especially the patient who will be receiving the treatments."

Integrity's manufacturing facility was certified by TÜV SÜD Product Service GmbH. Headquartered in Munich, Germany and founded in 1866, TÜV SÜD is one of the world's leading technical service organizations with more than 17,000 employees across 600 locations and partners with clients wherever they are in the world. United by the belief that technology should better
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