Millstone Medical Outsourcing LLC

Millstone Medical Outsourcing LLC is a contract manufacturing and post-manufacturing services provider headquartered in Mississippi serving medical device manufacturers globally. Founded in 2000, the company specializes in packaging, testing, logistics, and quality assurance for completed medical devices. Core capabilities include: packaging and assembly with ISO Class 7 cleanroom operations; quality-critical inspection and validation engineering; finished goods distribution and reverse logistics management including bone and tissue storage with cold-chain capability; set building and loaner management for surgical instruments; and comprehensive in-house testing services. Testing portfolio encompasses bioburden, sterility, bacterial endotoxin, microbial identification, particulate analysis, cytotoxicity, sterilization validation (gamma and ethylene oxide), EO residual testing, preservative efficacy, peel strength, dye penetration, bubble emission, accelerated aging, and environmental monitoring. The company operates 276,000 square feet of facility space with a 25,000-square-foot ISO 17025-certified laboratory featuring a world-class BI sterility suite for EO sterilization validation. FDA-registered and ISO 13485:2016 certified. Serves 50+ customers worldwide, including top-10 orthopedic device manufacturers. Offerings include pre-validated packaging solutions, system integration services, pharma-device distribution, and ImplantBase platform. Primary markets: orthopedics, surgical devices, and robotic-assisted surgery equipment.