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Medical Device Testing Companies
The ATS Family of Companies’ proven expertise in the relevant internationally recognized analysis methods allows us to be one of the industry’s best medical device testing companies. We offer an expert team of highly trained engineers and a 24-hour operation to help clients execute their test plans.
What Medical Devices Do
Medical devices help solve healthcare problems. They help save human lives from serious disease or injury and cure health conditions, along with proper medication and treatment. As these are life-saving devices, validating their quality is vital before putting them on the market.
Why Medical Device Testing Is Necessary
Having high product quality us essential in the medical industry. Not only is quality morally and ethically necessary for manufacturing companies, but multiple organizations (such as the United States Food and Drug Administration (FDA)) mandate it by enforcing strict standards. Under these guidelines, manufacturers must document every step of their medical device’s development to meet safety and functionality requirements.
A manufacturer can obtain clearance or approval for their product by working with medical device testing companies. This provider will perform extensive analysis on the product, verifying that it is safe and suitable for patient use.
What Sets Us Apart from the Rest
The ATS Family of Companies has been a trusted partner in medical device testing for over 20 years. Our clients’ test results help them meet regulatory requirements imposed by numerous agencies, including FDA and CE marketing approval. We provide our clients with high-quality medical device testing services by providing rapid responses, reliable test results, and professional reports. Furthermore, we have among the highest number of accredited medical device testing methods of all United States medical device testing companies.
Medical Device Testing We Offer
- Axial compression testing
- Shear testing
- Tensile testing
- Torque testing
- Fatigue testing
- Non-standard testing
- Instrument and life cycle testing
- Lot verification testing
- Dedicated screw testing
- Wear and simulation testing
Accreditation and Quality Standards
The ATS Family of Companies holds an ISO/IEC 17025:2017 accreditation (A2LA Cert No. 2142.01) for the highest number of medical device testing methods of any United States company. Our lab performs medical device testing and evaluations according to recognized ASTM and ISO standard specifications appropriate to our testing application. Both these qualification aspects set the Family of Companies apart from our competitors by reducing costs, establishing credibility, and improving efficiency.
The Family of Companies has medical device testing labs that equip manufacturers with the tools to get it right from the start. We get medical device manufacturers to market faster for less by helping them uphold their quality and safety standards.
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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