About Us

CSN Consulting Services is a company dedicated to helping other companies grow and be successful. We specialize in quality management and regulatory support for companies accessing the medical device market in the United States, Canada and the European Union. By leveraging our experience and expertise in the field of medical device development and manufacturing, we help our clients implement the tools they need to get their device to market faster, while still maintaining the high level of quality expected by end users.

We offer customized solutions for the implementation of robust quality management systems (QMS) designed to meet the regulatory requirements of the FDA, Health Canada and the European Union. We tailor each QMS to meet the needs of our clients based on their size, location and device classification to ensure they will be successful in their intended markets.

Regulatory approval is often the biggest hurdle a company can face and the number one milestone targeted by investors. We work closely with engineers and designers to develop a strong design history file suitable for regulatory submission, including FDA 510(k) clearance, Health Canada medical device licence approval and EU CE marking. Our goal is to develop a regulatory strategy that has the highest chance of success in the shortest amount of time.