WillowWood Achieves ISO Certification

June 12, 2019

Contact: Lisa Watkins
740.869.3377 ext. 106

WillowWood Achieves ISO 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.”