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FDA Medical Device Testing
The Applied Technical Services (ATS) Family of Companies helps clients navigate the challenges of obtaining clearance for FDA medical device testing and approval. Our experts supply companies with a plethora of expertise, as well as cost and time savings.
Our consulting specialists provide regulatory consulting services with a faster clearance/approval average than the industry standard. We have completed more than 200 successful 510(k) submissions. Furthermore, we have an average review time of 131 days—46 days faster than the industry average. By choosing us as a consultant for your FDA medical device testing, clients get their products to market considerably quicker than their competitors.
A Brief Overview of the FDA
The Food and Drug Administration (FDA) ensures the safety and security of food, drugs, and medical devices in the United States. The process of achieving regulatory compliance is very stringent. Products must receive clearance for sale and distribution before undergoing review. Manufacturers must then maintain oversight of products after they arrive on the market.
How the Approval Process Works
FDA approval is almost always mandatory before manufacturers can market or sell a product that might pose the potential risk of illness or injury. First, manufacturers must present a premarket approval (PMA) application and clinical testing results. After this submission, the FDA will rigorously review the product to identify the benefits and the risks. They are less inclined to approve a product if they assess a greater potential risk associated with the product than any potential benefit.
Medical Device Classifications
- Class I: Low-risk devices not intended to sustain or support life
- Elastic bandages
- Hand-held surgical instruments
- Class II: Medium-risk devices subject to more scrutiny than Class I devices but do not sustain or support life
- Powered wheelchairs
- Infusion pumps
- Class III: High-risk devices that receive rigorous testing due to the fact they are intended to sustain or support life
- Heart valves
- Metal-on-hip joints
FDA Medical Device Testing Compliance Consulting Services
Manufacturing clients need an FDA medical device testing compliance consultant. Our labs take an active role, assisting clients with preparations for even the most rigorous of approval processes. We offer multiple FDA compliance services, such as regulatory support, quality system development and improvement, 510(k) submission, and much more. With all these services at your fingertips, you can smoothly sail down the path to gaining and maintaining clearance for your product.
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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