BETHESDA, Md., Oct. 3 /PRNewswire/ -- Innovative Neurotronics, Inc. (IN, Inc.), a wholly-owned subsidiary of Hanger Orthopedic Group, Inc., announced today 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 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,” President of IN, Inc. Jeff Martin 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 community and is also a requirement to obtain marketing approvals by several countries such as 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.
“Achievement of both ISO certifications is a significant milestone in our plans for international expansion,” President and Chief Operating Officer of Hanger Orthopedic Group Tom Kirk said. “It facilitates our mission of bringing emerging Myo-Orthotics technology products to the European Union and beyond. Patients and health care providers across the globe can rest assured they are receiving high quality devices from IN, Inc.”
Cleared for marketing by the FDA in September 2005 and officially launched in the United States on May 1, 2006, IN, Inc.'s first product, the WalkAide(R) System, treats a form of paralysis or weakness of the legs known as “foot drop” due to stroke, spinal cord injury, traumatic brain injury, and other pathologies such as multiple sclerosis and cerebral palsy.
About Innovative Neurotronics, Inc.: Specializing in the field of functional electrical stimulation, Innovative Neurotronics, Inc. identifies emerging Myo-Orthotics Technologies(TM) developed at research centers and universities throughout the world that use neuromuscular stimulation to improve the functionality of an impaired limb. Innovative Neurotronics, Inc. is a wholly owned subsidiary of Hanger Orthopedic Group, Inc. , the world’s largest provider of orthotic and prosthetic (O&P) patient care. Headquartered in Bethesda, Maryland, Hanger owns and operates 621 patient care centers in 46 states including the District of Columbia, with 3,389 employees including 1,012 practitioners (as of 6/30/06). For more information on Innovative Neurotronics, Inc, visit http://www.ininc.us. For more information on Hanger, visit http://www.hanger.com.
Certain statements included in this press release are forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Please refer to the Company’s SEC filings for factors that could cause actual results to differ materially from the Company’s expectations.
CONTACT: Jennifer Bittner of Innovative Neurotronics, Inc., +1-301-280-4869, jbittner@hanger.com.
Innovative Neurotronics, Inc.
CONTACT: Jennifer Bittner of Innovative Neurotronics, Inc.,+1-301-280-4869, jbittner@hanger.com
