FALL RIVER, Mass., April 20 Millstone Medical Outsourcing announced today that the company, specifically the Memphis, TN, facility, registered with the Federal Drug Administration (FDA) as a human tissue bank, under regulation 21CFR1271, in order to expand services to manufacturers of products containing human cells or tissues used in surgical procedures, such as orthopedic implants. In addition, Millstone has completed specific registration and licensing requirements necessary to store and distribute human tissue and bone products in six states and is pursuing registration or licensing in four more. Millstone, outsource partner to the nation's top orthopedic companies, is the fast-growing provider of advanced inspection, clean room packaging, loaner kit processing, and distribution services to medical and dental device manufacturers worldwide.
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Registration with the FDA as a human tissue bank entails fulfillment of a wide variety of technical requirements related to environmental controls, equipment, supplies, labeling, tracking, as well as processing, storage, and distribution. The human tissue bank protocols will be provided in conjunction with the Memphis facility's services, including warehousing and distribution, returns processing, and loaner kit processing. The Memphis location was selected to enable customers to take advantage of later ship times, which will reduce transit times, enhance quality, and decrease costs.
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"At Millstone we are continually looking for innovative ways to serve our customers," said Christopher Ramsden, Chief Executive Officer. "Registration as a human tissue bank allows us to offer customers a broader range of services that enhance quality control and cost savings."
About Millstone Medical Outsourcing
Millstone Medical Outsourcing is a leading provider of customized outsourcing solutions to the medical device industry. With a client roster of over 50 prominent companies in the orthopedic sector alone, including nine of the top ten, Millstone delivers superior quality service, unparalleled expertise, and guaranteed ROI. The company offers advanced inspection, sterile and non-sterile packaging, loaner kit processing, and distribution services to device and product manufacturers worldwide. Millstone is privately-held and operates state-of-the-art facilities in Fall River, MA, and Memphis, TN. The company is FDA registered and ISO certified by BSI, Inc. to ISO 13485: 2003. For more information, please visit www.millstonemedical.com.
SOURCE Millstone Medical Outsourcing
