Medical Device Contract Manufacturing
Full Service Contract Engineering, Manufacturing, and Service Partner
Arterex provides comprehensive, integrated contract manufacturing services for everything from components to Class I, II, and III medical devices. We have the engineering expertise and manufacturing capabilities to ensure quality, speed, and a smooth transition into the marketplace.
Our team can partner with you to turn your concepts into reality in our manufacturing facilities in North America, Europe, Asia and North Africa. We are:
- ISO 13485:2016 certified
- FDA registered
- cGMP compliant
- ISO Class 7 & 8 clean rooms
- Model & prototype assembly labs
- Manufacturing scalability
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
- Full service medical device design and development
- Class 7 & 8 cleanroom assembly, test, and packaging
- Implantable device manufacturing
- Global supply chain management
- High precision, tight tolerance injection molding
- Tubing extrusion
- Metal fabrication and machining capabilities
- Single use device (SUD) and Electromechanical device (EMD) manufacturing, assembly & packaging
- Two shot, three shot, insert and overmolding
- 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
- Two shot, three shot, insert and overmolding
- 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
Tubing Extrusion
- Precise tight tolerance single lumen tubing
- Multi lumen
- Profiles
- Paratubing and parawire extrusions
- Over extrusions of wires and metal profiles
- Inline and offline secondary operations including punching, skiving, grinding, tipping, printing and overmolding
Metal Fabrication and Machining Capabilities
- 2 & 4 Axis Laser Micro Machining and Cutting
- 5-Axis CNC Machining and Milling
- Wire EDM Capabilities
- 2 & 4 Axis Laser Welding
- 5 Axis Grinding
- Vertical and Horizontal Grinding
- Laser Marking and Chemical Etching
Metal Fabrication and Machining Capabilities
- 2 & 4 Axis Laser Micro Machining and Cutting
- 5-Axis CNC Machining and Milling
- Wire EDM Capabilities
- 2 & 4 Axis Laser Welding
- 5 Axis Grinding
- Vertical and Horizontal Grinding
- Laser Marking and Chemical Etching
Clean Room Assembly
- Class III Implantable Product Manufacturing
- 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
Single Use Device (SUD) and Electromechanical Device (EMD) Manufacturing, Assembly & Packaging
- 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
Single Use Device (SUD) and Electromechanical Device (EMD) Manufacturing, Assembly & Packaging
- 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
Materials Joining
- Laser beam welding
- Resistance welding
- Tungsten inert gas (TIG) welding
- Ultrasonic welding
- Adhesive bonding
- RF welding
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
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
Routine Sterilization Oversite
- Product Load Release
- Quarterly Dose Audit (Gamma)
Execute and Oversite of Sterilization Validation
- Ethylene Oxide
- Gamma Irradiation
- Autoclaving (Steam Sterilization)
Execute and Oversite of Sterilization Validation
- Ethylene Oxide
- Gamma Irradiation
- Autoclaving (Steam Sterilization)
Secondary Operations
- Automated and manual assembly
- RF Welding, laser welding, ultrasonic welding
- Pad printing, foil stamping, silk screening
- Heat staking, heat sealing
- PVC resin compounding
- Kitting and Sterilization Management