Millstone Medical Outsourcing Takes On Quality Advantages
Millstone Medical Outsourcing Gains Certified ISO 13485, Hires Experienced Quality Manager
05/13/2008
Fall River, MA — Millstone Medical Outsourcing announced today that the company successfully expanded its ISO 13485 certified quality system to the Memphis, Tenn., facility (ISO, International Organization for Standardization, is the world’s largest developer and publisher of international standards). In addition, the company hired Gary Stevens, a highly-experienced quality engineer, to serve as quality manager for the Memphis location. Millstone, outsource partner to the industry’s top orthopedic companies, is the fast-growing provider of aftermarket services, start-up solutions, and premier contract packaging services for medical device manufacturers worldwide.
Millstone Medical’s Memphis facility achieved its ISO 13485 certification without any major or minor non-conformities or observations, according to the assessment report produced by the company’s registrar, BSI Management Systems. ISO 13485, which is a specific designation for medical devices, provides certification for washing/disinfection, inspection, processing, and distribution of loaner kits and finished goods.
“With the new certification, which is really the standard for medical device quality systems, and our new quality manager, Millstone’s Memphis facility is primed and ready to provide the best in loaner kit processing and distribution services for medical device manufacturers worldwide,” said Kelly Lucenti, president of Millstone Medical Outsourcing. “In addition, our Memphis facility is strategically located near the hubs of two major carriers to allow for extended service hours and expedited shipping.”
Stevens comes to Millstone Medical with over 25 years of experience in quality management and engineering. He served as director of quality for Premier Tool, Inc., a medical instrument manufacturer, and as validation program manager for Gyrus ENT, LLC, a medical device manufacturer. His expertise includes the development of product quality assurance programs, the application of Total Quality Management principles, FDA regulatory compliance, and process validation.
“We are very excited to welcome Gary to the Memphis team,” said Shawn Martin, Millstone’s operations manager, Memphis facility. “His knowledge and leadership will be invaluable as we continue to grow, and he will help ensure that customers can expect the same caliber of quality they have relied on from Millstone for years.”
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