Medical Device Regulatory Compliance Testing
The Applied Technical Services Family of Companies (FoC) provides medical device regulatory compliance testing for manufacturers. A medical device is an instrument, material, appliance, or implant used to diagnose, treat, and prevent injuries or illnesses. These devices range from single-use devices such as catheters and syringes to complex spinal implants. Our medical device testing lab helps manufacturers comply with regulatory requirements and secure eligibility in the marketplace.
Our Medical Device Testing Capabilities
Our experienced medical device testing experts use their decades of collective experience to conduct a wide range of medical device tests and evaluations. We evaluate medical devices in various conditions to gather information and evaluate how devices respond to specific conditions and stresses. The information we collect assists manufacturers as they do the following:
- Ensure Regulatory Compliance
- Gain Access to Various Markets
- Identify Risks with Their Products
- Build Trust with Customers
We offer an extensive list of dental, joint, spinal, and extremity medical device testing services, including:
- Axial Compression Testing
- Life Cycle Testing
- Fatigue Testing
- Torsion Testing
- Lot Verification Testing
- Custom Testing
Why is Medical Device Regulatory Compliance Important?
Medical device regulatory compliance ensures the safety and effectiveness of healthcare products. Established by entities like the U.S. FDA or the European Medicines Agency, these regulations set design, manufacturing, quality control, labeling, and post-market surveillance standards. Third-party medical device testing labs ensure that medical devices meet these rigorous standards, reducing the risk of harm. Regulations also promote transparency and accountability by providing healthcare professionals and consumers with accurate information about the device’s risks and benefits. This transparency fosters trust in the medical device industry, reassuring stakeholders that the products are thoroughly tested and monitored. Failure to comply with regulatory standards can lead to serious legal, financial, and reputational consequences, as well as potential patient harm.
Our Commitment to Quality
The Applied Technical Services Family of Companies upholds internationally recognized quality standards to ensure our clients receive high-quality services from various departments. We provide professional inspection, testing, and consulting engineering services for commercial and industrial clients in multiple industries. Our A2LA-accredited facilities offer the following services:
- Mechanical Testing
- Chemical Testing
- Calibration Services
- Nondestructive Services
- Electrical Testing
Please submit a web request or call +1 (888) 287-5227 to speak with inquire about our medical device regulatory compliance testing.
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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