US Market

Welcome to the USA

The US medical device market is one of the largest and most influential in the world, offering a wide range of opportunities for manufacturers, suppliers, and healthcare professionals. To ensure patient safety and product effectiveness, the market is heavily regulated by various agencies and governed by stringent regulations.

Key agencies involved in the regulation of medical devices in the US include the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). The FDA is responsible for pre-market approval, post-market surveillance, and ensuring compliance with quality and safety standards. The CMS, on the other hand, plays a crucial role in reimbursement policies and coverage decisions. Understanding the regulatory landscape and navigating the complex requirements is essential for success in the US medical device market. Stay tuned as we explore topics such as FDA approval processes, regulatory updates, market trends, and much more, to help you make informed decisions and thrive in this dynamic industry.

Registration Process

Sobel | Your partner on every step

Identify Conformity Route




Appoint US Agent

for NON-US Manufacturer

FDA Assessment

Audits and submission file (e.g. 510k) assessment

Ready to sell

Start commercalization

Our Services

Regulatory Affairs Support

Navigate the complex world of regulatory affairs with our comprehensive Regulatory Service. From strategic planning to gap analysis and continuous support, ensure alignment with key regulations (e.g. 21 CFR 807) for a seamless business operation.

Quality Management Support

Sobel Consultancy’s MDR Quality Management Support offers unparalleled assistance in harmonizing your existing quality management system with the requirements of 21 CFR 820. Leveraging years of experience in medical device quality management, we ensure that your business stands tall amidst regulatory shifts and changes.

Risk Management

Manage medical device risks effectively with ISO 14971-based Risk Management Support. Expert planning, comprehensive risk analysis, and effective control measures are at your disposal. A final report evaluates overall risk, ensuring safety and compliance.


Biological Evaluation

Experience seamless Biological Evaluation for medical devices, meticulously aligned with ISO 10993 standards. Our all-inclusive service offers evaluation planning, material characterization, toxicological assessment and study monitoring if needed. Trust our experts to deliver a comprehensive report affirming device safety. With us, you receive the full package, eliminating any concern.


Clinical Evaluation

Experience our Clinical Evaluation Service, meticulously structured to align with crucial standards required to compile your submission documentation. Tailored for medical devices, it encompasses planning, exhaustive literature reviews, product verifications, validations, and clinical data analysis. Trust our experts to deliver a comprehensive report confirming your device’s safety and performance.

Submission File

An embodiment of our deep-rooted expertise in compiling robust medical device documentation. This service aligns with key regulations (e.g. 21 CFR 807), guaranteeing a comprehensive, authoritative submission files, such as the pre-market notification (510k) or premarket approval (PMA), that resonates with assurance and reliability. Trust our dedicated problem-solving approach for your needs and witness the exceptional difference we bring to your compliance journey.


US Agent service

Secure your place in the USA with Sobel Consultancy’s US agent service. Specialized in medical device regulatory affairs, strengthening your global footprint.


Unleash your potential in the complex realm of medical devices through our comprehensive training programs. Our curriculum is designed to cater to your specific requirements, ranging from acquiring a deep understanding of US and European regulation fundamentals to conducting meticulous toxicological evaluations. Rest assured, our training programs are tailored to meet the highest professional standards in the industry.

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