Medical Device Regulatory Consulting Services
The Applied Technical Services Family of Companies (FoC) offers medical device regulatory consulting services that help medical device manufacturers qualify their products for the marketplace. Medical devices are an essential part of the lives of millions of people worldwide. Due to their importance and sensitive nature, these devices must undergo extensive testing that vets their quality, safety, and functionality. Our medical device testing experts work alongside our clients to ensure their products meet specifications while complying with industry standards and regulations.
About Our Medical Device Regulatory Consulting Services
Our medical device testing experts have decades of collective experience using mechanical testing to determine the strengths and weaknesses of medical devices. Our ISO / IEC 17025 accredited labs have the state-of-the-art equipment needed to simulate the real-world applications of medical devices, ensuring that the products can withstand the expected amount of wear and tear. Our ability to conduct mechanical tests on medical devices makes us adept at consulting on matters about medical device designs and regulations. Upon completion of our testing, we share highly detailed reports of our findings with our clients and regulation agencies, maintaining an objective and transparent approach throughout the process. We offer an extensive list of medical device regulatory consulting services, including the following:
- Audit regulatory consulting
- Clinical literature review
- Compliance support
- Distribution support
- FDA consulting
Why are Medical Device Regulations Important?
Medical device manufacturers must comply with an extensive list of regulations designed to protect patients, medical providers, and patients from the risks associated with poorly vetted medical devices. Failure to comply with rules will not only result in a device’s inability to be sold in the marketplace, but it can also lead to the following issues:
- Ineffective or even outright dangerous products
- Fines and legal penalties, including potential criminal charges
- Consumer dissatisfaction with products and distrust for a manufacturer
Contact Us
Please consider the ATS Family of Companies if your company needs a trustworthy medical device testing firm. Contact us today, by calling +1 (888) 287-5227 or completing an online service request.
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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