Challenges
A Canadian Start-up bringing a novel medical technology to market faces challenges navigating Canada’s stringent medical device regulatory landscape. The company turned to Qaralogic to guide them in ensuring full alignment with Health Canada’s Regulations (CMDR) and MDSAP while improving processes and speed to market.
Solutions
End-to-end regulatory strategy, confirming risk classification and developing a complete, submission-ready technical dossier. A compliant MDSAP QMS was implemented to support both Canadian approval and future global expansion, while structured Health Canada interactions ensured efficient reviews and rapid resolution of regulatory questions.
Results
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Faster Software releases
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Increased team confidence in QA
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Decreased in Operations time and cost
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Full Compliance maintained
Conclusion
Through comprehensive regulatory strategy, technical validation, and targeted process improvement, Qaralogic enabled the start-up to bring a groundbreaking VR-based visual field testing device to market. The device now stands as a credible, regulated innovation in digital ophthalmic diagnostics, opening new opportunities for accessible, portable vision assessment across Canada and globally.