Clinical Evaluation
The clinical evaluation is a critical component of any regulatory submission to the U.S. FDA. It provides structured, evidence-based justification for the safety and performance of a medical device, serving as the foundation for both 510(k) and PMA applications.
We can support your company with end-to-end clinical evaluation services tailored to meet FDA expectations.
Our process combines regulatory expertise, scientific rigor, and strategic planning to ensure your documentation is complete, compliant, and submission-ready. High-quality evidence for confident regulatory submissions!
How We Support Your Clinical Evaluation in the USA
What is a Clinical Evaluation?
A Clinical Evaluation is a structured process that compiles and analyzes clinical data to demonstrate the safety and performance of a medical device.
For FDA submissions, this includes a Clinical Evaluation Plan (CEP), an in-depth literature review, and a detailed Clinical Evaluation Report (CER) that supports your 510(k) or PMA. And we can help your company with:
Develop a customized Clinical Evaluation Plan outlining objectives, scope, data sources, and evaluation strategy
Conduct thorough literature searches to gather clinical data on the device or equivalent products
Analyze available clinical and scientific data to support safety and performance claims
Identify any gaps and provide strategic recommendations to address them
Compile a high-quality, FDA-aligned CER report with clear, structured, and defensible conclusions
Ensure all documentation fits seamlessly into your submission for regulatory compliance
Why do you need this service?
Whether through 510(k) or PMA, the FDA expects strong clinical evidence. A properly structured CER medical device report helps your submission align with regulatory expectations from the start.
We help demonstrate that your device works as intended and doesn’t pose unacceptable risks, using data that stands up to FDA scrutiny.
Clinical evaluation is complex. But we focus only on what’s essential, helping you avoid unnecessary studies and streamline your path to approval.
A well-prepared Clinical Evaluation Report does more than support your FDA submission—it protects your product, builds trust, and strengthens your brand. That’s why having a highly qualified team by your side, like Sobel, makes all the difference.
Looking for Clinical Evaluation Assistance?
At Sobel, clinical evaluation is a strategic step toward successful approval. Our team combines regulatory insight, scientific expertise, and clear communication to help you submit with confidence and stand out in the marketplace.
Let us guide you from plan to CER report—with quality, precision, and full alignment to FDA expectations.
