BONEZONE

DEC 2016

Published by ORTHOWORLD Inc., BONEZONE delivers strategic sourcing & product commercialization solutions to orthopaedic device company decision makers and their partners.

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Profile Featured Millstone Medical, leading provider of customized solutions to the medical device industry, has over 15 years of experience in organizing the chaos of outsourced supply chains. Operating three environ- mentally controlled and strategically located facilities in the U.S., Millstone offers clean room packaging, medical device specific warehousing, distribution, loaner kit management, advanced inspection and after-market services. With an unparalleled focus on quality, Millstone Medical is the partner you can trust with your post-manufacturing needs. Offering a wide range of post-manufacturing services to medical device manufacturers. Sterile Packaging 2 Class 10,000/1S07 Cleanrooms Ultrasonic Cleaning & Passivation Real Time Particulate Monitoring System Sencorp Tray & Bar Sealers Vacuum & Nitrogen Flush Sealing Syringe Fill Operations Argon Gas Glove Box Operations Fast Lane Pre-Validated Packaging Peel Testing Loaner Kit Processing Kitting & Assembly Washers/Disinfectors & Autoclaves Functional Testing & Mechanical Inspection Custom Web Portal Functionality Live Global Kit View Live Bill of Materials Comparison Lot Code Traceability within Sets Real-Time Visibility of Field Inventory Shipping until 12AM EST Advanced Mechanical Inspection CMM Programming & Inspection Optical Comparator Measurement & Tolerance Verification Geometric Dimension & Tolerance Verification Caliper & Micrometer Warehousing & Distribution Environmentally-Controlled Storage Inventory Control & Maintenance Order Fulfillment Customer Online Inventory Management Real-Time Inventory Tracking Online Visibility: Order Status & Internal Processing Ambient to -80 degrees Celsius Storage Validation Engineering Comprehensive Package Integrity Testing Sealing Validations Distribution Validations Accelerated Aging Sterilization Validations (ETO & Gamma) Label Design & Production PFMEA Development Post-Market Services Field Return Processing Repackaging Refurbishment Consigned Inventory Management Re-box/Re-label/Over-label Shrink Wrapping Real-Time Visibility of Inventory Instrument Recycling Additional Services: Oracle & Rackspace Software Applications Sterilization Management Tier 1 Procurement ADVANCED INSPECTION, STERILE AND NON-STERILE PACKAGING, LOANER KIT PROCESSING, FIELD RETURNS, HCT/P STORAGE & DISTRIBUTION Millstone Medical Outsourcing 580 Commerce Dr Fall River, MA 02720 United States 508-679-8384 (phone) 508-679-8414 (fax) Website www.millstonemedical.com Founded 2000 Contact Tom Williams twilliams@millstonemedical.com Facilities 115,000 sq. ft. in Fall River, MA 270,000 sq. ft. in Olive Branch, MS Staff 450 employees Registration/Certification FDA Registered, including registration as Human Tissue Bank ISO Certified by BSI, Inc. to 13485:2003 HCTP Compliant with 21 CFR 1271, 820 VAWD Accredited State Registered as Medical Device Distributor State Registered for Direct to Patient Distribution

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