Our solutions

Navigate U.S. regulations with confidence. Sobel provides expert support in Regulatory Affairs, Quality Management, Risk Management, and Clinical Evaluation, helping you meet FDA requirements efficiently. Our team offers strategic guidance to streamline compliance, mitigate risks, and help to ensure a smooth submission process.

U.S. FDA compliance

Regulatory Compliance Solutions for the U.S. Medical Device Industry

Ensure your medical device meets FDA regulations with expert regulatory compliance solutions. Get strategic support in regulatory submissions, quality management, or risk assessment. We can guide you through every step of the compliance process. With our expertise, you can streamline approvals and successfully navigate the U.S. medical device industry confidently and efficiently.

Our Services in Regulatory Compliance Solutions

Expert support will help you confidently bring your medical device to the U.S. market. Discover the key steps of the FDA process and how Sobel can assist you.

Regulatory Planning

Risk Assessment

QMS Setup

Evaluation and Documentation

Post-Market Support

Regulatory Affairs Support

Navigate regulatory affairs with us, covering planning, gap analysis, and ongoing support.

Quality Management Support

Assistance in harmonizing your quality management system aligned with 21 CFR 820.

Risk Management

Manage device risks with ISO 14971 support, including analysis, control, and final report.

Biological Evaluation

An evaluation aligned with ISO 10993, including planning, assessment, and reporting.

Clinical Evaluation

Planning, literature reviews, verifications, validations, and clinical data analysis.

Submission File Elaboration

We create robust submission files aligned with 21 CFR 807 for 510k or PMA approval.

U.S. Agent service

Secure your USA presence with our U.S. agent, specializing in medical device regulations.

Training

Unlock your potential with our training programs on U.S. regulations and evaluations.

Navigating FDA regulations can be complex, but our Regulatory Affairs Service helps ensure your medical device meets all compliance requirements.

We conduct thorough gap analyses on submission files like 510(k) and PMA, identifying missing elements and guiding you to streamline the approval process. Our team collaborates with you, refining your documentation, reducing delays, and improving approval chances.

Compliance doesn’t end with approval. U.S. medical device regulations are constantly evolving, so we provide ongoing support, using modern tools and efficient project management to simplify compliance and keep your business up-to-date.

Whether you’re preparing your first submission or optimizing existing documentation, we offer the expertise to help you easily navigate every step.