Bethesda, MD — 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
“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®
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™ 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. (NYSE:HGR), 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.