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Medical Device Mechanical Testing
Applied Technical Services’ Family of Companies provides medical device mechanical testing to help ensure industry standard compliance and safety.
The Importance of Medical Device Testing
Medical devices are crucial to patient care. They directly impact human lives, producing vital observations and data. Devices must undergo testing to ensure optimal product functionality, efficiency, safety, and quality. Testing companies will evaluate devices for these specific qualities before manufacturers are able to put them out on the market.
How Medical Device Testing Works
Manufacturers must ensure that their medical devices are safe and effective by gaining proper assurance from regulatory bodies. They seek out medical device mechanical testing companies to conduct appropriate testing and analysis to eliminate any potential device risks.
Medical device mechanical testing companies play a significant role in every step of the approval process, from the early idea testing phase to final design validation and verification. Testing labs produce proper procedures, performance reports, and reviews. They also implement custom testing protocols to help manufacturers meet quality and safety standards set by regulatory entities, such as the FDA.
Types of Medical Device Mechanical Testing We Provide
- Axial compression testing
- Dedicated screw testing
- Fatigue testing
- Instrument and life cycle testing
- Lot verification testing
- Non-standard testing
- Shear testing
- Tensile testing
- Torque testing
- Wear and simulation testing
Our Family of Companies
We staff some of the industry’s most knowledgeable and skilled mechanical testing experts, engineers, certified lab technicians, machinists, regulatory consultants, and project managers. Our medical device testing laboratories conduct the most efficient and accurate testing services in order to help medical device projects succeed.
Our experts provide exceptional customer service seamless communication, and optimal solutions training. Our services are sensitive to the fast-paced product developmental environment, causing us to deliver reproducible and reliable results with rapid response times.
The ATS Family of Companies Offers:
- 20 + years of experience
- Additively manufactured component testing
- Comprehensive and proven solutions
- Custom testing procedures
- Experts in titanium subject matter
- Extensions of client's team, providing timely execution and expert guidance
- Regulatory-ready test reports
- Trusted Reputation
Compliance Standards and Regulations
All ATS companies maintain ISO/IEC 17025 accreditation to ensure accurate reporting with dependable results. Our mechanical testing lab tests and evaluates medical devices under ISO and ASTM standards and features an extensive list of testing capabilities. These qualifications promote consistent excellence, improve operational efficiency, and reduce client costs.
In addition to our ISO 17025 accreditations, all ATS companies employs an ISO-recognized Quality Management System (QMS), which upholds our organization-wide dedication to confidentiality. Each of our employees undergoes in-depth training in QMS and document handling, ensuring all client relationships are strictly confidential.
Contact Us
Our medical device mechanical testing assures manufacturers that their product is safe and functional. Ranging from tongue depressors to heart valves, we will verify that your is able to achieve proper functionality. Contact the medical device mechanical testing experts at ATS’ Family of Companies today to request a free quote or schedule 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 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