FDA Medical Device Consulting Services
The Applied Technical Services Family of Companies (FoC) offers FDA medical device consulting services. Medical devices have improved the lives of millions of people worldwide and their continuous advancements will ensure that the number steadily rises. The FDA regulates these medical devices, ensuring that they’re effective and safe for their end users, and our medical device experts help businesses comply with and prepare for these regulations.
Why Does the FDA Establish Medical Device Regulations?
The FDA regulations the sale of medical devices in the US ensuring that these devices are well-intended and safe to use. The FDA requires that manufacturers comply with their regulatory requirements before the device enters the market. The FDA divides medical devices into three categories, Class 1, 2, and 3 devices. The regulations strengthen as the class increases due to the increased sensitivity of the device’s purpose. For example, an elastic bandage is a Class 1 medical device whereas a pacemaker is a Class 3 device. If not properly designed or used, the pacemaker poses significantly more risk than a bandage, requiring more testing and scrutiny.
Our FDA Medical Device Consulting Services
Our medical device testing experts consult with clients, helping them navigate the ever-evolving landscape of medical device regulations. Our staff is trained according to the standards of the Regulatory Affairs Professionals Society (RAPS), many of which have also earned their Regulatory Affairs Certification (RAC). In addition to our FDA quality and regulatory consulting services, we offer the following:
- Regulatory support, including compilation, deficiency support, and review
- Distribution and shipping validation
- Compliance support
- Quality system improvement and development
- Educational courses and programs
- Sterilization and cleaning verification
Why is FDA Compliance Important for Medical Device Manufacturers?
The FDA enforces regulations to ensure medical device manufacturers develop safe and effective products that pose minimal user risk. Noncompliance with FDA standards can present a series of serious issues for manufacturers, including:
- Fines
- Legal actions
- Consumer dissatisfaction due to poor product performance or quality
Contact Us
Please submit an online request or call +1 (888) 287-5227 to speak with an ATS representative about our FDA medical device consulting 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