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Medical Device Testing Laboratories
The ATS (Applied Technical Services) Family of Companies provides mechanical testing capabilities at our medical device testing laboratories. We help these manufacturers ensure quality, functionality, and safety in their products through our expertise in performing various testing methods.
Why Medical Device Testing Laboratories Are Necessary
Medical device testing laboratories serve a crucial role in the development of medical devices. They assist manufacturers in ensuring that their product’s performance adheres to strict standards and regulations. Furthermore, these joint efforts prevent faulty equipment from entering the market and potentially causing harm to patients.
Medical Device Testing We Offer:
Axial compression testing applies a force to compress a specimen. This testing method provides yield and ultimate strength and represents a large portion of fatigue testing since it closely replicates stresses the materials must survive throughout their service lives.
Fatigue testing applies cyclic loading to a structure or coupon. This test identifies a sample’s lifespan, location, and susceptibility.
Instrument and life cycle testing adds mechanical functions onto a unit inside a moderated environment. This test shows the failures, weaknesses, and strengths of the sample.
Lot verification testing confirms whether each lot of product meets the minimum safety and quality requirements before it hits the market.
Non-standard testing encompasses various types of testing. It applies to all new or unusual devices with no accepted testing standard.
Shear testing applies parallel stresses to a sample to cause sliding failure. This test determines the shear strength of a material.
Torsion testing twists a sample around its axis to acquire information such as maximum torque, shear modulus, and torsional shear stress. It can also locate a material’s breaking angle or two materials’ interfaces.
Tensile testing determines the force required to break a composite or stretch the specimen to its breaking point. It provides information on the metallic material’s tensile strength, yield strength, and ductility.
Wear and simulation testing evaluates the performance of a device in everyday conditions to determine if it will fulfill its functions correctly. This test allows manufacturers to improve and optimize their designs before large-scale manufacturing and implantation.
Dedicated Screw Testing
Driving torque testing evaluates the force it takes a screw to penetrate a known substrate. Manufacturers use the data from testing to optimize designs and not overload the bone. Pull-out testing identifies the resistance a screw shows against being pulled out of its substrate.
Medical device testing laboratories frequently perform this test immediately after a driving torque test. Sheer, fatigue, and level testing evaluate the amount of force a screw must withstand while levering or moving due to a rod or plate.
Custom Testing
Our Family of Companies works on numerous projects with no set testing standard every year. Our labs possess the experience needed to understand what regulatory agencies around the world find acceptable. We retain a deep knowledge of test designs to meet our client’s needs.
Partnering together, we can navigate the testing process—whether novel or cutting-edge designs. From inspection to realization, we conduct countless types of testing, and we center everything we do around the goal of approval.
Our Medical Device Testing Laboratories
From spinal to extremity, the Family of Companies covers a wide range of medical device testing. We specialize in mechanical testing backed by our state-of-the-art medical device testing laboratories. Our operation runs for 24-hours a day. We employ a team of highly skilled scientists and technicians to assist clients in executing their test plans.
Our Family of Companies
Our Family of Companies possesses the proper tools to respond to a fast-paced product development industry. We guarantee our clients high-quality medical device testing services with reliable results, professional reporting, and rapid response times. Above everything else, our medical device testing services support fast product development in a wildly competitive industry.
We Provide:
- Additive manufactured and component testing
- Comprehensive and proven solutions
- Custom testing procedures
- Extensions of client's team, providing timely execution and expert guidance
- Regulatory-ready test reports
- Expertise in titanium subject matter
- Trusted Reputation
- 20 + years of experience
Industry-Recognized Certification
We are an ISO/IEC 17025:2017 Test Laboratory Accreditation Certificate #2142-01-A2LA holder through the American Association for Laboratory Accreditation (A2LA). We are a qualified and capable company that performs testing and evaluations for medical devices. We help manufacturers comply with completed medical devices’ ISO/ASTM guidelines.
All lab technicians must undergo extensive training to abide by our Quality Management System (QMS) and confidential document handling procedures. We uphold organization-wide confidentiality with every one of our employees.
Contact Us
With the Applied Technical Services (ATS) Family of Companies, you are not just testing; you are actively working toward getting your medical device on the market as quickly as possible. We invite you to tour our medical device testing laboratories and see our operations directly.
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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