Medical Device Mechanical Testing Regulations
Prostheses and implants can do great harm if deficient, so the FDA sets stringent mechanical testing requirements for medical device manufacturers and distributors. Devices intended for bodily implantation must prove they can withstand the loads and conditions within and without a human body. As such, manufacturers and distributors may request mechanical testing from qualified third-party labs before submitting a device for 510(k) clearance or Premarket Approval (PMA).
Medical Device Testing with ATS FoC
The ATS FoC offers a variety of medical device tests and services for product verification and validation. We work with devices and assemblies classified as moderate to high-risk (FDA Classes II and III) to ensure quality and safety. Clients may contact us throughout the design and development of an implant or component for regular testing.
Implants and Prostheses:
- Spinal prostheses and implants
- Dental implants
- Hip implants
- Shoulder implants
- Lower-limb prostheses
Systems and Devices:
- Computer-Assisted Surgery (CAS) Systems
- Fixation components
- Screws
- Plating
Standards-Based Testing
After development, we can test function, quality, and safety according to industry standards from ASTM, ISO, and other relevant organizations. Our technicians can also determine a device’s mechanical and material properties.
Some of our most popular mechanical tests and standards include:
- Axial Compression Testing: ASTM F2267
- Dedicated Screw Testing: ASTM F2502, ASTM F543
- Instrument and Life Cycle Testing
- Fatigue Testing: ASTM F1160, ASTM F2423, ISO 12189
- Lot Verification Testing
- Shear Testing: ASTM F1044, ASTM F1160, ASTM F1829
- Tensile Testing: ASTM F1147
- Torsion Testing: ASTM F543
- Wear Testing: ASTM F1714, ASTM F2025, ASTM F2423, ISO 18192-1
Meet the ATS FoC
We are a network of consulting engineering, calibration, testing, and inspection firms known collectively as the ATS Family of Companies (FoC). Founded in Atlanta in 1967, ATS has built a reputation for responsiveness and dependability. Today, we operate ISO/IEC 17025-accredited labs in strategic locations nationwide. ATS also meets ISO 9001:2015 requirements for a Quality Management System.
With over 20 years of experience in medical device testing, the ATS FoC is qualified for third-party testing and verification. Our employees have undergone extensive training in confidentiality, testing, and reporting. Additionally, we can tailor ASME, ISO, and other relevant standards-based testing to suit our clients’ needs or create non-standard tests custom to client specifications.
Contact Us
Please call +1 (888) 287-5227 to learn more about how the ATS FoC can support your medical device’s compliance with mechanical testing regulations.
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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