Regulatory Consultant Medical Devices
The ATS Family of Companies offers regulatory consultant services for medical devices, helping to guide manufacturers through the complexities of achieving and maintaining compliance with regulations and safety standards.
Regulatory Consultant Services for Medical Device Manufacturers
As medical devices can be responsible for patient comfort, mobility, and organ functionality, making their safety and reliability extremely important. ATS’ medical device compliance consultants help clients navigate the various standards and regulations that govern the development, manufacturing, marketing, and distribution of medical devices. Our consultants are experts in understanding the strict and specific rules set by regulatory bodies like the U.S. Food and Drug Administration, the European Medicines Agency, and other international health organizations. Consultant expertise helps to ensure that medical devices meet all safety and quality standards before they are introduced to the market.
Our regulatory consultants provide hands-on assistance to guide medical device manufacturers through the regulatory approval process, starting with compiling and submitting technical documentation containing detailed information about the device, its design, the manufacturing process, risk assessments, clinical data, and quality control protocols. ATS’ experienced consultants ensure that every aspect of the product meets the necessary regulatory guidelines, which vary depending on the classification and intended use of the device.
Maintaining Compliance for Medical Devices
One of the most significant challenges in the medical device industry is adhering to constantly evolving regulations. In the United States, medical devices are classified as Class I, II, or III, with more extensive requirements based on the device’s purpose and its potential risk to patients. The regulatory consultants at ATS determine the correct classification of client devices and the appropriate strategy to achieving market approval, whether through the FDA’s 510k premarket notification process, premarket approval, or another regulatory route.
In addition to guiding the regulatory submission process, our consultants can help clients maintain compliance throughout the product’s lifecycle. This includes advising on post-market monitoring for the safety and performance of devices once they are in use. ATS’ experts assist in setting up systems for reporting incidents, conducting periodic safety updates, and ensuring ongoing compliance with regulatory standards.
The Medical Device Consulting Experts at Applied Technical Services
At Applied Technical Services, we pride ourselves in offering a wide range of comprehensive services for various industries and disciplines, offering clients a one-stop shop for all their testing, analysis, inspection, certification, and compliance needs. Call us today at 1 (888) 287-5227 for additional information or a free quote on regulatory consultant services for medical devices, or submit a request form on this page.
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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