Innovative Neurotronics Earns ISO Certification

Innovative Neurotronics Inc. (IN Inc.), Bethesda, Maryland, a wholly owned subsidiary of Hanger Orthopedic Group Inc., also based in Bethesda, announced October 3 that it has achieved ISO 13485:2003 and ISO 9001:2000 certification from BSI Inc., the world's leading quality management systems registrar. The achievement of ISO certification verifies that IN Inc. has implemented comprehensive quality management systems (QMS) in product development, operations, shipping, and customer service.

"Innovative Neurotronics is committed to developing and delivering the highest quality products based on emerging neuromuscular technologies," IN Inc. President JeffMartin said. "Achievement of the ISO 9001 and 13485 certifications validates this commitment. We will continue to instill confidence in our patients, referral sources, research alliances, and international partners by regularly monitoring our business operations and delivering on promises of service excellence."

Developed by the International Organization for Standardization (ISO), a network of the national standards institutes of 161 countries, the ISO 13485:2003 standard is an internationally recognized quality management system standard for medical devices. Certification supports the CE marking process for products sold within the 25-nation European Union and is also a requirement to obtain marketing approvals by several countries, including Canada and Japan.

Also developed by the International Organization for Standardization, the ISO 9001:2000 certification is an international reference for quality management requirements in business-to-business dealings. It signifies a global benchmark in customer satisfaction and product quality.

IN Inc. decided to pursue the ISO quality management certifications as part of its commitment to expand its business capabilities and broaden its neuromuscular stimulation offerings, the company said.

"Achievement of both ISO certifications is a significant milestone in our plans for international expansion," said Hanger President and COO Tom Kirk. "It facilitates our mission of bringing emerging Myo-Orthotics TM technology products to the European Union and beyond. Patients and healthcare providers across the globe can rest assured they are receiving high quality devices from IN Inc."

Cleared for marketing by the US Food & Drug Administration (FDA) in September 2005 and officially launched in the United States on May 1, 2006, IN Inc.'s first product, the WalkAide® System, treats foot drop due to stroke, spinal cord injury, traumatic brain injury, and other pathologies such as multiple sclerosis and cerebral palsy.

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