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We help you register your Software as a Medical Device by guiding you through classification, evidence preparation, quality requirements, and licensing so your software meets Health Canada’s expectations and enters the Canadian market smoothly.
Software as a Medical Device must follow Health Canada’s Medical Devices Regulations, but the expectations for documentation, validation, cybersecurity, and clinical evidence differ from traditional hardware devices.
Your risk classification determines the level of evidence required and whether you need a Medical Device Licence (MDL), an MDSAP-certified quality system, or supplemental technical files.
At Quality Smart Solutions, we help you understand these requirements and prepare a complete submission that aligns with Health Canada guidance. We identify gaps early, streamline your documentation, and support you from classification through licensing so your software is ready for review.
We determine your SaMD’s risk classification under Health Canada rules and identify the correct licensing pathway, documentation needs, and evidence requirements.
We review your validation reports, performance testing, cybersecurity documentation, and clinical evidence to ensure everything aligns with Health Canada expectations.
We prepare or support your MDL application for Class II–IV SaMD, including device description, intended use, risk controls, safety information, and supporting data.
We review Instructions for Use, software descriptions, warnings, claims, and online materials to ensure accuracy and compliance with Health Canada requirements.
We support ongoing compliance, including amendments, software updates, evidence updates, and regulatory maintenance.
Explore articles, blogs, and videos on SaMD, medical device licensing, and digital health compliance.
Your software qualifies as SaMD when it performs a medical function such as diagnosing, treating, preventing, or monitoring a health condition. We review your product’s purpose and help you confirm its regulatory status.
Class II–IV SaMD need an MDL before you can sell them in Canada. Class I SaMD do not require an MDL, but you still need to meet all safety and compliance obligations. We help you determine your class and the licensing steps you need.
You need evidence that shows your software works as intended and remains safe. This may include validation testing, usability studies, cybersecurity documentation, clinical data, and risk management files. We help you build and organize this evidence so it meets Health Canada expectations.
Timelines depend on your classification and the completeness of your evidence. We help you move faster by preparing accurate submissions and addressing gaps early.
Yes. We support global companies entering the Canadian market and act as your regulatory representative when needed.
You need IEC 62304 compliance when your SaMD follows a software development lifecycle that Health Canada expects. We assess your development process and help you prepare the documentation that shows alignment.
Health Canada classifies your SaMD based on how its outputs influence clinical decisions and patient outcomes. We help you analyze your intended use, assign the correct risk class, and understand what this means for your evidence and licensing pathway.