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Medical Device Reliability Testing
The ATS Family of Companies carries out exceptional medical device reliability testing in a timely and cost-effective manner. This testing is vital in the development process of up-and-coming device designs.
Medical Device Testing on Implants
Medical device reliability testing is an essential tool for the safety analysis of implants. Our laboratories focus on an array of implants, such as dental, extremity, joint, and spinal. Each implant requires a different type of medical device reliability testing. We specialize in several different medical device testing methods. For example, we can perform numerous tests on dental implants, including fatigue, torque, and tension.
Why Medical Device Reliability Testing is Needed
Product efficiency and quality are not only morally and ethically imperative to all manufacturing companies—multiple organizations and agencies mandate them. These oversight entities regard medical devices with even greater scrutiny than the average consumer product. Due to the strict standards enforced by regulatory bodies like the United States Food and Drug Administration (FDA), manufacturers must document and trace every step of a medical device’s development back to the safety and functionality requirements.
When Risks Occur
Technicians conduct tests to determine if the product poses a risk to patient health, providing analysis and recommendations. Manufacturers are then able to mitigate or eliminate these risks. Once this remediation process is complete, they must monitor the medical device throughout its market life to confirm that no new or unexpected risks arise. If they do, the FDA will enforce additional analysis and control measures.
How We Can Help
Manufacturers often seek out companies that assist in reliability testing to help them obtain results. The ATS Family of Companies offers broad medical device reliability testing capabilities. These methods replicate the product’s intended use before it hits the market to ensure its safety and efficiency.
Our Testing Capabilities Include:
- Tensile testing
- Shear testing
- Torsion testing
- Fatigue testing
- Wear and simulation testing
- Taber abrasion testing
- Instrument and life cycle testing
- Dedicated screw testing
- Lot verification testing
- Non-standard testing
- Custom testing
Quality Standards
The ATS Family of Companies is committed to delivering high-quality medical device testing services to our customers. We have ISO/IEC 17025:2017 accreditations and an ISO-recognized Quality Management System (QMS). Our employees receive thorough training in QMS and confidential document handling.
Our company provides customers with quality services, giving them competitive advantage by lowering costs, establishing credibility, elevating profitability, and improving efficiency. If your product or device is ready for testing, choose the Applied Technical Services (ATS) Family of Companies: a medical device reliability testing lab that helps clients achieve timely and effective market success.
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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 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 Testing
- Prosthetic Testing
- Prosthetic Testing Services