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Medical Device Testing Services
The ATS (Applied Technical Services) Family of Companies offers medical device testing services for clients who need FDA approval on their medical devices.
Why Medical Device Testing Services Are Important
Medical devices are vital to patient care, directly impacting human lives by producing critical data and observations.
Medical device testing services are an essential step in the developmental process of medical devices as they help ensure product quality, safety, and efficiency. Testing for these qualities is a mandatory part of the process when getting a product out on the market.
How Medical Device Testing Works
Manufacturers must prove that their medical devices are safe and effective by supplying regulatory bodies with proper assurance. They seek out medical device testing services to perform appropriate testing and analysis to eliminate potential risks.
From early idea testing to final design validation and verification, medical device testing serves a role in every step of the process. Our labs produce development procedures, as well as performance reviews and reports. Furthermore, they implement custom testing services to help manufacturers meet stringent safety and quality standards set by the FDA and other regulatory bodies.
Types of Medical Device Testing We Offer:
Tensile testing measures how much force will break a specimen or composite and the amount of stretch it is susceptible to before reaching a breaking point. This test provides knowledge about the ductility of a metallic material, its yield strength, and its tensile strength.
Taber abrasion testing performs accelerated wear testing to evaluate abrasion resistance. This test supports quality and process control, research and development, and material evaluation projects.
Torsion testing twists a sample along an axis or fixed point. This test obtains details such as shear modulus, shear stress, maximum torque, the interface between two materials, and the angle of breakage on a material.
Fatigue testing provides manufacturers with a critical understanding of the material and component performance in real-world scenarios over time. This test also identifies critical locations, validates the safety of structures sensitive to fatigue, and generates data such as crack growth and fatigue life.
Shear testing applies stress to a sample so that it experiences sliding failure on a plane parallel to any opposing froes. This test determines the specimen’s shear strength.
Lot verification testing provides FDA with real-time information to monitor the quality of each batch of products it regulates.
Instrument & life cycle testing apply cyclical mechanical forces to a unit inside a controlled environment. This test helps manufacturers meet the threshold for compliance and ensures quality for customers.
Wear & simulation testing allows manufacturers to evaluate the wear performance of designs and materials under intended service conditions.
Dedicated screw testing encompasses driving torque, pullout, lever, shear, and fatigue testing.
Non-standard/custom testing provides help to clients wanting to test their medical devices with no set standard.
Our Team of Mechanical Testing Experts
We employ the industry’s most knowledgeable and skilled mechanical testing experts, engineers, lab technicians, machinists, regulatory consultants, and project managers. Our medical device testing laboratories provide the most efficient and accurate services to help our client’s projects succeed. All our experts offer the best customer service, communication skills, and training for optimal solutions.
Our Testing Scope Includes:
- Dental implant testing
- Extremity implant testing
- Joint implant testing
- Spinal implant testing
Compliance with Standards and Regulations
We maintain an ISO/IEC 17025:2017 accreditation for the highest number of medical device testing methodologies out of any corporation in the US. Our lab tests and evaluates medical devices according to ISO and ASTM standards appropriate to the testing application type. These qualifications set us apart from competitors by promoting consistent excellence, improving operational efficiency, and reducing client costs.
Our medical device testing laboratories provide manufacturers with the knowledge they need to design safe and functional products. We get manufacturers’ medical device products on the market faster by aiding them with safety and quality standards. Reach out to us today for a free quote on our services!
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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