FDA Medical Device Consultant Services
The Applied Technical Services Family of Companies offers a wide range of consulting services to help clients achieve compliance with regulatory standards and requirements, including FDA medical device consultant services.
Medical Device Consultant Services
ATS’ FDA medical device consulting services guide clients through the extensive and complex process of attaining compliance with standards and regulatory requirements set by the Food and Drug Administration. Bringing a medical device to market involves a detailed and complicated process that requires a deep understanding of regulatory requirements, scientific principles, and clinical data. Our diverse consulting services assist clients through every stage of the product life cycle, from concept development to post-market data analysis. ATS helps clients ensure that medical devices meet FDA standards for safety, performance, ultimately streamlining the process and avoiding potential delays or rejections. Applied Technical Services’ medical device consultants specialize in regulatory strategy development. Before manufacturers can submit a device for approval, they must determine which regulatory pathway is most appropriate. This could involve the Premarket Notification process, Premarket Approval, or the De Novo classification, depending on the risk level and intended purpose of the device. Our consultants help manufacturers understand these options and decide the best strategy based on the specific product. This early-stage guidance is invaluable, helping clients avoid common pitfalls that could result in costly delays or even failed submissions.
ATS’ FDA medical device consultants provide support in preparing required documentation for submission to the FDA, including clinical and non-clinical data compilation, creating detailed technical files, and ensuring that all testing and evaluations are conducted in accordance with FDA guidelines. Our consultants also conduct audits, help implement quality management systems, and advise on staff training. After achieving compliance, we offer post-market analysis to monitor device performance and report any adverse events to the FDA.
The Medical Device Consultants at Applied Technical Services
ATS offers consulting services for an impressive range of purposes, industries, and disciplines, ranging from predictive maintenance consulting to FDA medical device consultant services. With nearly six decades of business experience, ATS is proud to be the preferred consulting services provider for some of the nation’s most esteemed companies, organizations, and businesses. Give us a call today to request additional information, a free quote, or to schedule service. A member of our customer service team will be happy to assist at 1 (888) 287-5227.
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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