To achieve licensure, Tibion demonstrated compliance with the federal Good Manufacturing Practice (GMP) / Quality System Regulation (QSR) as part of a rigorous audit conducted by an inspector from the FDB. This regulation governs the requirements for a comprehensive management system for the design and manufacture of medical devices. The FDB works in partnership with the federal Food and Drug Administration (FDA) to regulate medical devices in California.
“Tibion has reached another milestone in our goal towards commercializing the PowerKnee,” said Tibion CEO Kern Bhugra. “We are committed to providing high quality products to assist patients dealing with the loss of muscle function.”
About Tibion
Tibion is a privately held company located at NASA Research Park, Moffett Field, California. The company’s mission is to develop smart medical devices and therapies that address the needs of musculoskeletal and neuromuscular deficiencies. Tibion’s products are enabled by patented innovations encompassing a broad range of disciplines, including orthotics, biomechanics and embedded control systems. The company’s first product, the PowerKnee, is a wearable bionic device for the leg to enhance rehabilitation and help patients improve muscle strength and function as well as to provide assistance with activities of daily living.
For more information, visit the Company’s website at www.tibion.com.
Contact:
Tibion Corp. Jean M. Nelson, 650-694-7384, x121 jean@tibion.com
