WillowWood Achieves ISO 13485:2016 Certification
WillowWood has achieved ISO 13485:2016 certification. The company, certified by NSF International Strategic Registrations, met all requirements for having a comprehensive quality management system specifically for the design and manufacturing of medical devices as set by the International Organization for Standardization (ISO).
Shortly after becoming ISO 13485:2003 certified in February 2017, WillowWood began planning and preparing for the 2016 certification standards. The 2016 revision to ISO 13485 focuses on risk management and risk-based decision making, as well as accounts for changes in technology, regulatory requirements, and more closely aligns ISO requirements with FDA regulations.
“Obtaining ISO 13485:2016 certification allows us to continue to improve our products and processes in a formalized, quality-focused, manner while also giving us a framework to develop new products that meet or exceed patients’ needs and are safe with meeting all compliance regulations.” commented Steve Huggins, WillowWood’s Quality Assurance Manager.
WillowWood currently has over 20 global distributors in countries including Germany, Australia, Japan, Brazil, Russia, and England. ISO certification is often requested or required of companies entering new markets or securing product contracts with foreign governments.
“Everyone at WillowWood is dedicated to making consistently high quality prosthetic products,” said WillowWood Chief Operating Officer John Matera. “Achieving this level of ISO certification is a reflection of our commitment to quality and to serving our industry.”
About WillowWood Global LLC
Based in Mount Sterling, Ohio, WillowWood Global (www.willowwood.com) is an industry leading designer, manufacturer, and distributor of prosthetic products, including liners, feet, vacuum systems and components. Recognized for its products’ superior innovation, quality, and patient outcomes, WillowWood’s portfolio includes the Alpha® family of liners, the Koa® LP and Meta® families of high-activity feet, the LimbLogic® vacuum system, and the OMEGA® CAD system. For over 115 years, WillowWood’s prosthetic products have helped individuals with limb loss find comfort and functionality, remain active and live life to the fullest.
