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Case Studies
Fast-Track Regulatory Approval for a Visual Acuity App in Canada
Challenges
The client faced multiple regulatory hurdles, including limited internal knowledge of Canadian medical device regulations and the absence of formal Standard Operating Procedures. A key challenge was defining a precise Intended Use statement that would avoid an unnecessarily high risk classification, all while meeting an extremely compressed regulatory timeline.
Solutions
The team worked closely with the client to clearly define the Intended Use and align the product with a lower-risk regulatory pathway. Required SOPs were developed and implemented to meet Health Canada expectations, including complaint handling and post-market surveillance. Hands-on compliance training was also provided to prepare the team for ongoing regulatory responsibilities.
Regulatory foundation established
Health Canada approval in days
Accelerated MDEL issuance
Early market entry achieved
First-mover advantage secured
Results
CONCLUSION
This case demonstrates how focused regulatory strategy, combined with practical implementation and close collaboration, can enable rapid approval and early market access for low-risk digital health products.
TESTIMONIAL
"Working with Hasnaa was an exceptional experience. Their deep expertise in medical device regulations and the Health Canada approval process made a complex journey smooth and efficient. Their strategic guidance and attention to detail ensured our submission was well-prepared and successful. I highly recommend Hasnaa to any company navigating regulatory approvals." — Justin Asgarpour, CEO, EyecareX