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Millstone Medical's Memphis facility achieved its ISO 13485 certificationwithout any major or minor non-conformities or observations, according to theassessment report produced by the company's registrar, BSI Management Systems.ISO 13485, which is a specific designation for medical devices, providescertification for washing/disinfection, inspection, processing, anddistribution of loaner kits and finished goods.
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"With the new certification, which is really the standard for medicaldevice quality systems, and our new Quality Manager, Millstone's Memphisfacility is primed and ready to provide the best in loaner kit processing anddistribution services for medical device manufacturers worldwide," said KellyLucenti, President of Millstone Medical Outsourcing. "In addition, ourMemphis facility is strategically located near the hubs of two major carriersto allow for extended service hours and expedited shipping."
Mr. Stevens comes to Millstone Medical with over 25 years of experience inquality management and engineering. He served as Director of Quality forPremier Tool, Inc., a medical instrument manufacturer, and as ValidationProgram Manager for Gyrus ENT, LLC, a medical device manufacturer. Hisexpertise includes the development of product quality assurance programs, theapplication of Total Quality Management principles, FDA regulatory compliance,and process validation.
"We are very excited to welcome Gary to the Memphis team," said ShawnMartin, Millstone's Operations Manager, Memphis facility. "His knowledge andleadership will be invaluable as we continue to grow, and he will help ensurethat customers can expect the same caliber of quality they have relied on fromMillstone for years."
About Millstone Medical Outsourcing
Millstone Medical Outsourcing is a leading and innovative provider ofcustomized outsourcing solutions to the medical device industry. The companyoffers superior aftermarket services, customized start-up solutions, andpremier contract packaging services to medical device manufacturers worldwide.With tens of thousands of units processed each week for many of the industry'smost prominent companies, Millstone has significant expertise in a wide rangeof services. Superior quality service and increased ROI are what clients havecome to expect from Millstone Medical Outsourcing. The company isprivately-held and headquartered in Fall River, MA. Millstone is FDAregistered and ISO certified by BSI, Inc. to ISO 13485: 2003. For moreinformation, please visit http://www.millstonemedical.com.
SOURCE Millstone Medical Outsourcing
