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Material Testing Laboratory
The Applied Technical Services (ATS) Family of Companies offers our capabilities as a state-of-the-art material testing laboratory. This service is essential in the development process of up-and-coming medical device designs.
What Material Testing Is
Material testing is a well-known discipline that can determine the properties of medical device components. Material testing can take an array of forms, validating and verifying the performance of components under testing. These methods produce qualitative and quantitative results to inform manufacturers about their materials’ capabilities.
Why Material Testing Laboratories Are Needed
Medical devices made using faulty or weak materials can seriously damage patients. Regulatory bodies minimize these risks by issuing standards for manufacturing companies to adhere to during testing.
Material testing laboratories gather the data to inform manufacturers their product’s faults or weaknesses. Manufacturers can then make changes to the materials used, as well as the product’s overall construction.
When Risks Occur
If our technicians may discover risks in materials, they will provide manufacturers with test results so that clients may mitigate or eliminate them. Regulatory bodies, such as the Food and Drug Administration (FDA), will monitor the device materials throughout their market life to guarantee their quality and safety. They will also implement additional testing and control measures if any risks arise.
How Material Testing Laboratories Can Help
Manufacturers turn to material testing laboratories to assist them in gaining approval for their medical devices. Our Family of Companies offers a broad medical device material testing scope, allowing our labs to check for safety and functionality in materials and ultimately provide manufacturers with accurate results and reports.
Our Family of Companies
Our Family of Companies has achieved over 200 successful 510(k) submissions with the FDA. Our average review time is 131 days, 46 days faster than the industry average. The sector-specific expertise we offer helps manufacturers navigate the approval process that regulatory bodies enforce, and our customized approach allows them to achieve compliance quickly and efficiently.
We Possess
- Over 20 years of experience
- Custom testing and protocols
- Comprehensive and proven solutions
- Additive component and manufactured testing
- Regulatory-ready test reports
- Our trusted reputation
- Experts in titanium subject matter
- An extension of your team, providing expert guidance and timely execution
Our Material Testing Laboratory
Our expert team of engineers conducts material testing in our 24-hour laboratory. We provide a complete material testing service package, offering manufacturers a wide range of testing solutions.
Common Tests We Perform
- Fatigue testing
- Shear testing
- Torsion testing
- Tensile testing
- Dedicated screw testing
- Instrument and life cycle testing
- Taber abrasion testing
- Wear and simulation testing
- Custom testing
- Non-standard testing
- Lot verification testing
Quality Assurance
The ATS Family of Companies holds an ISO/IEC 17025:2017 Test Laboratory Accreditation Certificate after passing rigorous auditing by the A2LA, qualifying us to perform tests and evaluations on medical devices compliant with ASTM/ISO standards and guidelines. By observing and utilizing GLP (good laboratory practices), our Family of Companies ensures the integrity of our results with lab monitoring, planning, recording, and reporting. We deliver accurate, traceable, and reproducible reports to manufacturers.
Contact Us
Contact the Family of Companies to learn more about our material testing laboratory today!
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Medical Device Testing
ASTM Testing
- ASTM F1044 Shear Testing of CaP and Metallic Coatings
- ASTM F1160 Shear and Bending Fatigue of Coatings
- ASTM F1233
- ASTM F1264 Intramedullary Fixation Device Testing
- ASTM F1357 Articulating Total Wrist Implant Testing
- ASTM F1378 Shoulder Prostheses Testing
- ASTM F1541 ESFD Testing
- ASTM F1672 Patellar Prosthesis Testing
- ASTM F1714 Gravimetric Wear Assessment of Prosthetic Hip Design in Simulator Device Testing
- ASTM F1717 Spinal Implant Testing
- ASTM F1781 Elastomeric Flexible Hinge Finger Total Joint Implants Testing
- ASTM F1798 Spinal Implant Subassembly Testing
- ASTM F1820 Modular Acetabular Device Strength Testing
- ASTM F1829 Glenoid Locking Mechanism Shear Testing
- ASTM F1875 Fretting Corrosion Testing of Hip Implant Interfaces
- ASTM 2009 Modular Prostheses Taper Connection Testing
- ASTM F2025 Wear Assessment of Polymeric Components
- ASTM F2028 Glenoid Loosening Testing
- ASTM F2077 Intervertebral Body Fusion Device Testing
- ASTM F2183 Small Punch Testing
- ASTM F2193 Spinal Fixation Components
- ASTM F2267 Measuring Subsidence of Intervertebral Fusion Devices
- ASTM F2346 Standard and Dynamic Testing of Artificial Intervertebral Discs
- ASTM F2423 Wear and Fatigue Testing of Total Disc Prostheses
- ASTM F2502 Absorbable Plate and Screw Testing
- ASTM F2554 CAS System Precision Testing
- ASTM F2624 Static, Dynamic, and Wear Testing of Extra-Discal Spinal Implants
- ASTM F2624 Spinal Implant Dynamic Testing
- ASTM F2694 Lumbar Total Facet Prosthesis Testing
- ASTM F2706 Spinal Implant Fatigue Testing
- ASTM F2789 Mechanical and Functional Characterization of Nucleus Devices
- ASTM F2790 Static and Dynamic Testing of Total Facet Prostheses
- ASTM F382 Metallic Bone Plates Testing
- ASTM F384 Angled Orthopedic Fixation Testing
- ASTM F543 Metallic Medical Bone Screw Testing
- ASTM F564 Metallic Bone Staple Testing
ISO Testing
- Biocompatibility Testing for Medical Devices ISO 10993
- ISO-10328 Structural Testing of Lower Limb Prosthetics
- ISO 10993 Biocompatibility
- ISO 10993 Biocompatibility Testing
- ISO 10993 Testing
- ISO 10993 Testing Lab
- ISO 18192-1 Wear Testing for Intervertebral Disc Prostheses
- ISO 12189 Fatigue Testing of Flexible Spinal Implants
Medical Device Testing
- Fatigue Testing Lab
- Implant Testing
- Material Testing Laboratory
- Material Device Regulatory Compliance Testing
- Medical Device Testing
- Medical Device Testing Certification
- Medical Device Materials Testing
- Medical Device Materials Testing Consulting
- Medical Device Mechanical Testing
- Medical Device Mechanical Testing Regulations
- Medical Device Performance Testing
- Medical Device Product Testing
- Medical Device Reliability Testing
- Medical Device Standards Testing
- Medical Device Standards Testing Certifications
- Medical Device Testing Companies
- Medical Device Testing Services
- Medical Device Testing Lab
- Medical Implant Testing Lab
- Orthopedic Device Approval Testing
- Orthopedic Device Testing
- Prosthetic Testing
- Prosthetic Testing Services
- Prosthetic Testing Services
- Spinal Implant Testing