Delivering Outsourcing Solutions to Medical Device Manufacturers
Millstone Medical Outsourcing is a leading provider of customized outsourcing solutions to the medical device industry. Millstone’s customer roster includes more than 50 medical device manufacturers, including nine of the world’s top OEMs. With innovative programs designed to solve a wide range of challenges, Millstone has become a recognized thought leader in the medical device industry. Superior quality service and improved ROI are advantages customers expect from Millstone Medical Outsourcing. Millstone is FDA registered and ISO certified by BSI, Inc. to 13485: 2003.
Inspection, Packaging, Loaner Kit Processing, and Field Inventory Auditing
Since 2000, Millstone Medical Outsourcing has served as a strategic partner to medical device manufacturers worldwide. Millstone’s wide range of outsourcing options includes validation and engineering, advanced mechanical inspection, sterile and non-sterile packaging, loaner kit processing, field inventory auditing, and warehousing and distribution services. From the world’s top medical device manufacturers to emerging companies, Millstone collaborates with clients to develop comprehensive, effective programs to address specific business objectives.
Validation and Engineering Services
Comprehensive validation processes, from development to implementation, including:
- Package integrity testing (IQ, OQ, PQ)
- PFMEA development
- Label design and production
- Distribution testing
- Ultrasonic cleaning
- Accelerated aging
- High-level disinfection
- Sterilization (ETO and Gamma)
Advanced Mechanical Inspection
- Experienced team of Certified Mechanical Inspectors (CMIs)
- Optical Comparator and Computerized Measuring Machines (CMMs) with advanced programming capabilities
- Mechanical, dimensional, and etch verification
- Geometric Dimension and Tolerancing (GD&T)
- Caliper and micrometer measurement
- First Article Inspection (FAI), including visual inspection and non-conformance identification
Ultrasonic Cleaning and Passivation
- Separate clean lines for sterile and non-sterile process segregation
- Ultrasonic cleaning via robotic Branson Omni 2000, equipped with TDR 15 robotic transport arm and forced air dryer
- Integrated nitric acid passivation with continual flow rinse system
- Trumpf Vectormark VMc 1 Laser Marking System provides etching for critical part, lot, and CE mark information
Sterile and Non-Sterile Packaging
- Over 8,000 square feet of Class 10,000/ISO 7 rated clean room operating space
- Real-time Particulate Monitoring Systems
- Kitting and assembly, poly-bagging and tubing, boxing, labeling, and shrink wrapping
- Sterilization management services
Field Inventory Management (Loaner Kit Processing and Auditing Services)
- Inventory control and maintenance
- Custom ERP solutions, including loaner kit processing, web tracking, and sales order entry
- Loaner program management, including kit cleaning, disinfection, and sterilization
- Loaner kit expediting with guaranteed overnight shipping up to 11 pm EST
- Field returns processing, inspection, and restocking
- Inventory auditing
Warehousing and Distribution Services
- State-of-the-art facilities in Fall River, MA, and Memphis, TN
- Controlled storage conditions, including bone and tissue warehousing and distribution
- Complete product traceability
Reducing Costs, Enhancing Efficiency, Ensuring Quality, and Increasing Speed to Market
Millstone’s full suite of integrated services offers answers to the many challenges faced by today’s medical device manufacturers. As a trusted strategic partner, Millstone works closely with customers to establish programs that reduce costs, enhance efficiency, ensure superior quality, and increase speed to market. Millstone is committed to developing and implementing solutions that enable customers to stay more than a step ahead of their competition.
Operating state-of-the-art facilities in Fall River, MA, and Memphis, TN:
Headquarters
580 Commerce Drive
Fall River, MA 02720
Phone: 508.679.8384
Fax: 508.679.8414
MemphisDistribution Center
4800 Shelby Drive
Suite 101–Building F
Memphis, TN 38118
Phone: 901.881.5080
Fax: 901.362.2373