Technical documentation, Clinical Evaluation Reports (CERs) and quality assurance (QA) systems are essential components of medical device regulation in Canada. These documents provide assurance that a medical device is safe and effective for its intended use. Technical documentation includes technical drawings, specifications, and installation instructions, while the CER provides a comprehensive evaluation of the safety and efficacy of the device. The QA system ensures that product quality is maintained throughout the life cycle of a device, from manufacture to delivery. All three elements serve to ensure greater patient safety and public confidence in medical devices sold in Canada.