MCMINNVILLE, Tenn.--(BUSINESS WIRE)--Vilex Inc., a manufacturer of Orthopaedic medical devices, has received ISO 13485:2003 certification. This ISO standard specifies the requirements for comprehensive quality management systems in the design and manufacture of medical devices.
The achievement of this goal represents Vilex’s commitment to providing the highest quality products to its customers and emphasizes the Vilex culture of continuous improvement. The ISO standard provides additional assurance to current customers and conforms to the quality standards of the international market.
“Achieving ISO 13485 certification was identified as strategic priority in 2013. Our goal was not only to comply with all FDA guidance and regulations but to go a step beyond. I am pleased by the dedicated efforts of the Vilex team. We view this accomplishment as a significant step toward meeting the overseas demand for Vilex products, and we recognize the importance of the ISO standard in marketing Vilex products internationally,” explained Sylvia Southard, President of Vilex.
About Vilex Inc.
Vilex has over 15 years of industry experience as a manufacturer of cannulated bone screws, small joint resurfacing implants, memory staples, plates, IM nailing system, subtalar implants, external ring fixators, monorails, and power equipment for Orthopaedic and Podiatric surgery in the small bones of the foot, ankle, and hand. Learn more at www.vilex.com.