Biological Evaluation
For manufacturers planning to introduce medical devices into the Canadian market, a well-structured biological evaluation is essential. Our service is tailored to meet both global and Health Canada expectations, providing the technical foundation needed to support a successful submission.
Our biological evaluation service is designed to help manufacturers address the safety of their medical devices using internationally recognized frameworks and best practices.
With a combination of scientific rigor, regulatory insight, and technical precision, we support the development of strong biological safety documentation across a variety of regulatory environments.
Whether you’re preparing a new submission or compiling biological documentation for a legacy device with an established history of use, our team works closely with your data to build a tailored strategy for regulatory compliance.
How we support your biological evaluation process in Canada
Our support begins with the development of a clear Biological Evaluation Plan (BEP). This document outlines the strategy for assessing biological safety, including the device’s identification, categorization, and the regulatory pathway to be followed. For legacy devices, we prepare retrospective evaluations based on available documentation, including post-market data and previously conducted tests—particularly useful in cases where material characterization is not available.
Throughout this process, we can help you with:
Assess the completeness of existing documentation and identify data gaps;
Compare available information against regulatory expectations for biological risk evaluation;
Provide technical recommendations for addressing gaps, including possible test strategies where needed;
Review supporting data such as sterilization processes, chemical characterization, and stability studies;
Prepare the Biological Evaluation Report (BER), compiling all relevant data, critical analyses, and a documented risk assessment approach.
Our specialists also assist in defining a suitable evaluation strategy based on ISO 10993 and other applicable guidelines. The final documentation supports regulatory submissions in various markets, including Canada.
Why do you need this service?
Well-structured BEP: The Biological Evaluation Plan outlines a clear safety strategy, helping define documentation needs and avoid unnecessary steps.
Comprehensive BER: The Biological Evaluation Report brings together all relevant data and risk analysis to support regulatory submissions.
Well-documented evaluation: A complete and organized evaluation minimizes back-and-forth with authorities and helps accelerate the review process.
There are several important reasons why medical device manufacturers seek support for the biological evaluation of medical devices, especially when targeting the Canadian market.
If you want to save time and cost while receiving a well-prepared evaluation that adheres to ISO 10993 standards and Health Canada requirements — critical for product approval — partnering with Sobel is essential.
Working with a specialized consultancy offers structure, reduces uncertainty, and improves your product’s readiness for regulatory review.
Need Support with Your Biological Evaluation?
Our service brings together regulatory expertise, scientific insight, and a solid understanding of ISO 10993 principles to support your biological evaluation process from start to finish.
We work with transparency and precision at every stage—from strategic planning to documentation—adapting to your product’s specific needs.
Whether you need a complete biological evaluation plan or a well-structured report for Health Canada, we’re here to help you move forward with confidence.
