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Orthopedic Device Testing
The Applied Technical Services (ATS) Family of Companies is an accredited mechanical testing provider offering comprehensive orthopedic device testing. Our wide variety of testing standards places us at the forefront of the orthopedic device testing industry.
What Orthopedic Device Testing Is
Orthopedic device testing determines the stability of a medical implant and its impact on surrounding bone. This type of testing must replicate how an orthopedic implant will mechanically load within the host’s musculoskeletal system.
These devices must be subject to stringent testing protocols. The type of testing they will undergo depends upon the specific device and how it functions.
Why Orthopedic Device Testing Is Vital
Orthopedic device testing is vital in ensuring that devices function safely and satisfactorily. Working with an experienced testing company gives clients the confidence that they have the proper documentation before submitting their orthopedic device for review.
Common Orthopedic Devices Include:
- Implants
- Dental
- Spinal
- Joint
- Extremities
- Instruments
- Surgical screws
- Surgical staples
- Circular saws
- Scalpels
- Materials
- Metals
- Alloys
- Acrylic bone cement
- Polyethylene
- Calcium phosphate coatings
- Metallic thermal spray coatings
Types of Testing
Testing providers offer different types of mechanical testing methodologies for use with orthopedic devices. For example, reverse shoulder must undergo thorough loosening and fatigue testing, while the bone plates only need simple bending and pullout testing.
Another example is hip and knee implants. These devices require extensive testing since they replace larger, multifaceted joints. Different implants and components must undergo fatigue testing to verify that they can manage to ensure proper safety and efficiency.
Custom Testing
Testing companies can specify customized testing methods for the device under test. Since there are always an array of orthopedic devices in their developmental stages, it is critical that clients work with a fully equipped company ready to customize any test to find the correct solutions. We provide sample machining and fixture fabrication services in-house to support our clients’ custom testing needs.
Our Family of Companies
With more than 20 years of medical device testing experience, our Family of Companies is an innovator in the industry—especially when it comes to orthopedic devices. We provide full evaluations of orthopedic devices to ensure that surgical implants display the appropriate mechanical properties eventual clinical usage will require. Furthermore, we utilize our evaluations to produce rigorous reports ready for regulatory body submission.
Quality Assurance and Standards
The ATS Family of Companies has a deep understanding of the FDA requirements. Our relationship with the organization keeps us up to date with regulatory developments to provide clients with ample amounts of documentation to expedite review processes as often as they deem necessary.
Our 24-hour operation employs highly skilled mechanical engineers. We are an A2LA ISO/IEC 17025:2017 accredited mechanical testing lab specializing in various medical device testing methods. Contact us for a quote on your orthopedic device testing 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