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Medical Device Contract Manufacturing

Arterex provides comprehensive, integrated contract manufacturing services for everything from components to Class II and III therapeutic and diagnostic medical devices. our comprehensive range of capabilities, spanning medical device design, prototyping, and advanced engineering solutions. With a commitment to excellence, Arterex Medical seamlessly navigates the intricate realms of Class II and Class III devices, setting industry benchmarks. Contract manufacturer for medical devices for more information about manufacturing capabilities.

Arterex
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Medical Device Contract Manufacturing

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  1. Manufacturing Capabilities

  2. Full-service contract manufacturing partner Arterex provides comprehensive, integrated contract manufacturing services for everything from components to Class II and III therapeutic and diagnostic medical devices. We have the engineering expertise and manufacturing capabilities to ensure quality, speed, and a smooth transition into the marketplace. • • • • ISO 13485:2016 certified FDA registered cGMP compliant ISO Class 7 & 8 clean rooms Model & prototype assembly labs Manufacturing scalability Our team can partner with you to turn your concepts into reality in our manufacturing facilities in North America, Europe and North Africa. We are: • •

  3. LEAN manufacturing culture At Arterex, LEAN is more than a process—it’s baked into our culture. We use LEAN philosophies, tools, and systems to maintain an environment of continuous improvement. Our goal is to continuously improve the quality of your medical device while reducing cost. Comprehensive manufacturing capabilities Arterex partners with medical device market leaders to design, manufacture, assemble, and package components, single-use devices and electromechanical devices (EMD). Arterex Medical seamlessly navigates the intricate realms of Class II and Class III devices, setting industry benchmarks. Contract manufacturer for medical devices for more information about manufacturing capabilities.

  4. High Precision Injection Molding • Micro Molding in a class 8 clean room • 110 molding machines, 240,000 s.f. campus • High cavitation, tight tolerance • 2 shot, 3 shot with automated insert molding • 15,000 s.f. of class 8 cleanroom molding

  5. Clean room assembly • ISO Class 7 & Class 8 certified clean rooms • Complex disposable devices • Metal and plastic joining, including welding and bonding • In process and post assembly device testing • Sterile and non-sterile packaging • Sterile and non-sterile procedure bag manufacturing

  6. Electromechanical assembly • Design for Manufacturing (DFM) • Supply-Chain Management • Process Validation / Gage R&R • Assembly • Packaging and Distribution • Capability to Test and Burn-in • Full traceability – Lot and Serial numbers • ESD Controlled • Post-Production Support

  7. Materials joining • Laser beam welding • Resistance welding • Tungsten inert gas (TIG) welding • Ultrasonic welding • Adhesive bonding • RF welding

  8. Performance testing • Leak and Flow • Pressure • Continuity • Hi-Pot • Burn In Test • RFID Read/Write • Tensile/Peel • Accelerated Age • Real Time Age • ISTA Transit • Biocompatibility • Ethylene Oxide and Gamma Sterilization Validation

  9. Thanks

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