Our solutions
Navigate U.S. FDA regulations with confidence. Sobel provides expert support in regulatory affairs, FDA regulatory consulting, quality management systems (QMS), risk management, and both biological and clinical evaluations. We help you meet FDA requirements efficiently, supporting your company through every step of the regulatory pathway for medical devices.
Our team delivers strategic regulatory support to streamline FDA compliance, mitigate risks, and ensure a smoother 510(k) or PMA submission process.
U.S. FDA compliance
Regulatory Compliance Solutions for the U.S. Medical Device Industry
Meet FDA regulatory standards for your medical device with expert regulatory compliance solutions.
Whether you’re preparing your first FDA submission or optimizing existing documentation, we offer tailored support for:
Regulatory strategy
Quality management system implementation
Risk assessment in line with ISO 14971
We guide you through the full FDA regulatory process, helping you achieve faster approvals and confident entry into the U.S. medical device market.
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
Training
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
In accordance with the ISO 10993 series and the FDA Guide for the use of ISO 10993-1, including strategic planning, plan and reporting.
Clinical Evaluation
Strategic planning, systematic literature reviews, State of the Art (SoTA) and critical analysis of clinical data.
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.
Latest articles
Discover trends, tips, and expert insights to keep you ahead.
The Essential Role of PMS in Ensuring Compliance with MDR 2017/745: A Professional Guide
Understand the essential role of PMS in ensuring compliance with MDR 2017/745 and its impact on medical device safety and regulation.
MDR 2017/745 vs ISO 13485: Decoding Quality Management Requirements
Discover the key differences between MDR 2017/745 and ISO 13485 in quality management for medical devices.
Success in Product Design: The Importance of ISO 14971 in Medical Device Risk Management
Discover how ISO 14971 plays a crucial role in medical device risk management and ensures success in product design.
