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Element Materials Technology Company Profile

 

https://www.element.com/more-sectors/medical-device
E: [email protected]
T: (513) 771-2536

Address
3701 Port Union Rd., Fairfield, OH, 45014, United States
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Qualifications: Supplier to Medical Manufacturers

Markets Supplied: Worldwide

 

Who We Are

An ISO 17025 (A2LA) Accredited Laboratory, Element offers a wide range of medical device testing, specializing in orthopedic and cardiovascular devices. Our capabilities include a variety of static and fatigue testing, wear testing, and failure analysis on medical devices and implants.

Our wide array of fatigue testing capabilities also includes a full inventory of intravascular and orthopedic testing instruments. Featuring latest generation designs, our equipment incorporates computer control and data collection for accuracy, precision, and reliability.

For over 30 years, medical device manufacturers have chosen Element for device testing from feasibility R&D studies to full regulatory submissions. The responsiveness and expertise offered by the Element team helps us stand out as a trusted testing partner.


Our Capabilities

Orthopedic and Spine
Spine: Static and fatigue tests in a variety of loading modes including axial, torsional, shear, flexion/extension, bending, lateral bending, and axial rotation for:
·          Interbody Fusion Devices/Cervical and Lumbar Cages/VBRs
·          Artificial Disc Replacements
·          Interspinous Implants
Plate/Rod and Screw Systems
Hip Implant and Total Knee Replacement Systems
·          Hip Implant Wear Testing
·          Hip Fatigue Testing
·          Modular Connection Testing
·          Range of Motion and Impingement
·          Hip Implant Porous Coating Evaluation
·          Fretting Corrosion of Hip Device Connections
·          Failure Evaluation of Failed Hip Explants
·          Tibial Tray
·          Tibial Bearing Components
·          Femoral Implants
·          Femoral Component Fatigue
·          Tibial Insert Endurance under High Flexion
Cardiovascular, Peripheral, and Neurovascular

·          Pulsatile Durability (straight and curved)
·          Abdominal Aortic Aneurysm (AAA)
·          Heart Valve Testing
·          Lead Testing
·          Torsion Durability
·          Strength Characterization Testing
·          Stent Securement
·          Particle Counting and Analysis
·          Corrosion Testing
·          Intrinsic Elastic Recoil of Balloon-Expandable Stents
·          Dimensional Attributes of Vascular Stents
·          Gait Motion Durability
·          Bending Durability (linear and rotary)

Implantable, Diagnostic and Therapeutic Equipment

Element is UKAS accredited to BS EN ISO/IEC 17025:2005 and compliant to the medical EMC standard EN60601-1-2 and to ISO 9001:2008. We are a National Certification Body (NCB) and a Certification Body Test Laboratory (CBTL), and our commercial EMC test reports are accepted universally by Notified Bodies. 

·           Mains harmonic emissions
·           Flicker
·           Conducte...

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Element Materials Technology

https://www.element.com/more-sectors/medical-device
E: [email protected]
T: (513) 771-2536

Address
3701 Port Union Rd., Fairfield, OH, 45014, United States
View map

Follow  
LinkedIn   Blog