Clinical Evaluation
Structured, Evidence-Based Support for Market Approval in Canada!
Looking to launch your medical device in Canada? A solid Clinical Evaluation is one of the most important steps to get Health Canada’s approval and stand out in a competitive market.
At Sobel, we turn regulatory requirements into practical, high-impact documentation. From planning to reporting, we help you prove your device’s safety and performance with precision.
Saving time, reducing risk, and bringing you closer to approval.
How We Support Your Clinical Evaluation in Canada
What is a Clinical Evaluation Report?
It’s a detailed, scientific document that demonstrates your medical device’s safety, performance, and clinical benefit based on existing data.
Required by Health Canada and other global regulators, the Clinical Evaluation Report (CER) is a critical component of your device’s technical documentation—and a key step toward market approval.
We offer end-to-end support for your Clinical Evaluation Health Canada submission, combining technical expertise with regulatory precision. Here’s what we do:
Develop a customized Clinical Evaluation Plan (CEP) aligned with your device’s risk class and intended use
Conduct a literature review to gather relevant clinical data
Analyze and interpret available data from scientific publications, clinical studies, and post-market experience
Compile a clear, compliant Clinical Evaluation Report (CER) that meets Health Canada and international standards
Identify data gaps and suggest strategic solutions or justifications
Structure all documentation to fit seamlessly into your regulatory submission
Offer ongoing support to update your CER and CEP as part of your post-market strategy
Why do you need this service?
A compliant Clinical Evaluation is essential for obtaining and maintaining your medical device license in Canada. Without it, you risk delays, rejections, or market withdrawal.
Clinical data shows that your device performs as intended, under real-world conditions, and without posing undue risk. Our evaluations help you present that data clearly and convincingly.
Clinical evaluations can be complex and time-consuming. We streamline the process by focusing only on what’s necessary, helping you stay efficient, compliant, and on budget.
With the right structure and expert guidance, your documentation becomes a powerful tool to support approvals, reduce regulatory friction, and position your medical device for long-term success in the Canadian market.
Looking for Clinical Evaluation Assistance?
We bring together regulatory know-how, scientific expertise, and transparent communication to help you navigate Health Canada’s expectations with clarity and confidence. Our approach not only helps you meet the standard, it helps you exceed it.
Let our team help you build robust, regulation-ready documentation from plan to report.
