Medical devices
From device classification to Canadian licensing and regulatory compliance.
We help manufacturers, importers and distributors understand what their medical devices need for the Canadian market. From classification and licensing requirements to product documentation and operating procedures, we connect the technical work so you can move forward with a clear plan.
Let’s discuss your medical device
Start with a free initial consultation. No commitment required.
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Start with the right regulatory path. We assess your device’s intended use and classification, identify applicable licensing requirements, and carry out supplier and manufacturer assessments to highlight documentation gaps and practical next steps.
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We prepare MDL applications and supporting documentation for Class II and III devices. Support includes quality management system documentation, standard operating procedures, and reviews of labels and instructions for use against applicable Canadian requirements.
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Importing or distributing medical devices in Canada? We help determine whether an MDEL is required, prepare the application, and develop SOPs and supporting records relevant to your activities. The scope reflects your device classes, suppliers and business model.
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