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Case Studies
VR-Based Medical Device Case Study
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.
Faster Software releases
Increased team confidence in QA
Decreased in Ops time and cost
Full Compliance maintained
Results
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.
TESTIMONIAL
"Working with Hasnaa has been great! She has a deep understanding of the startup environment and is always on top of the deadlines. She collaborates effectively with the team and creates a good culture of quality which is something very important!"
— Dr. Abdullah Sarhan, CEO of Retinalogik