US Market

Welcome to the US Medical Device Market

Looking to bring your medical device to the USA market? Our Regulatory Affairs Service is here to guide you through every step. We specialize in making sure your device meets all the necessary FDA requirements with our expert gap analysis service for your existing submission files, like 510(k) and PMA. This means we’ll check your files thoroughly, find any missing pieces, and help you fix them to ensure a smooth approval process.

But that’s not all. We know the regulatory world is always changing, and keeping up can be tough. That’s why we provide continuous support to help you stay compliant every day. With our modern software tools and top-notch project management, we make the complex world of regulations simple and manageable. Whether it’s your first submission or you’re looking to improve your current documents, we’re here to assist.

Our goal is to make your journey to market as smooth and straightforward as possible. Let us handle the regulatory details, so you can focus on what you do best: creating innovative medical devices that improve lives. Trust us to be your partner in navigating the regulatory pathway to success in the USA medical device market.

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

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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