Medical Device Standards Testing Certification
The Applied Technical Services Family of Companies (FoC) provides medical device testing and certification for manufacturers. Our medical device testing labs recognize the importance of medical device evaluations, and our third-party product testing services help clients qualify their products for the marketplace.
Our Medical Device Standards Testing Certification Lab
The ATS FoC’s medical device testing lab features the state-of-the-art technology needed to evaluate our clients’ medical devices to ensure compliance with applicable guidelines, regulations, and requirements. We perform various types of medical device performance tests, including:
- Fatigue Testing
- Shear Testing
- Torsion Testing
- Life Cycle Testing
- Tensile Testing
- Simulation Testing
- Lot Verification Testing
- Taber Abrasion Testing
The Advantages of Our Independent Testing and Certification Labs
Our medical device testing labs offer independent evaluations of various medical devices, including dental, joint, and spinal implants, and help our clients with the following:
Compliance Assurance
We help manufacturers ensure that their medical devices comply with regulatory standards and requirements. We verify that materials and devices meet the safety, performance, and quality criteria for FDA approval.
Quality Control
Our medical device testing labs identify and address any performance or safety issues. We help manufacturers improve their products and meet end-users’ expectations.
Risk Mitigation
Our labs identify potential risks and hazards associated with device usage through rigorous testing. This information we gather through our tests and evaluations helps clients verify the safety of their products.
Market Access
Our reputable labs make it easier for clients to qualify their products for the marketplace. Our labs assist manufacturers as they seek compliance with regulatory standards. We make it easier for clients to gain approval and acceptance in domestic and international markets.
Innovation Support
Our abs promote innovation by offering guidance and feedback to manufacturers throughout the testing process. This support helps companies improve their products, overcome challenges, and develop solutions that meet the evolving needs of healthcare.
Confidence and Trust
Our labs help improve consumer confidence and trust in medical devices and their manufacturers.
The ATS FoC Experience
The Applied Technical Services FoC is ISO/IEC 17025 accredited, and we deliver high-quality services for a competitive price. We serve clients in a variety of industries nationwide, and we’ve earned an excellent reputation because of our client-centric approach to business. Our employees remain engaged and professional throughout the service process as we aim to provide the following:
- Prompt Service
- Informative Staff
- Regulation Compliance
- Precise Data Collection & Reporting
Please submit an online request for a free quote for our medical device testing standards or call +1 (888) 287-5227 to learn more.
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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