MedTech Regulatory Strategy: Navigating Canada & US Markets
🎯 Workshop Overview
MedTech Regulatory Strategy: Navigating Canada & US Markets
Understanding the regulatory approval process in Canada and the U.S. is essential for medtech startups. This workshop breaks down the key pathways, risk classifications, and strategic considerations to help you accelerate your product’s path to market.
📚 Learning Outcomes
By the end of this session, participants will:
Regulatory Pathways: Understand the main approval processes for Health Canada and the FDA.
Risk Classification: Learn how classification systems (Canada: Class I–IV, US: Class I–III) shape regulatory requirements, including for Software as a Medical Device (SaMD).
MDSAP Certification: Evaluate the benefits and drawbacks of pursuing Medical Device Single Audit Program certification.
Pre-Submission Meetings: Gain best practices for planning and conducting effective FDA Q-submission and other regulatory meetings.
Strategic Alignment: Discover how to integrate regulatory planning into your broader business strategy.
This workshop is ideal for clinicians, researchers, founders, and students who are building medtech solutions or work in the ecosystem and need a solid grasp of regulatory processes.
👩🏫 About the Speaker
Daniella Marx is a Regulatory Affairs and Quality Management Consultant with deep expertise in medical device quality systems, risk management, and international regulatory strategy. She holds a PhD in Biomedical Engineering from Toronto Metropolitan University and currently serves as a Project Manager at Docusys Corporation, where she supports medical device companies in navigating Health Canada, FDA, and EU regulatory requirements. Daniella brings hands-on experience with SOP development, MDSAP certification, and end-to-end regulatory submissions.
Workshop Details
📅 Date: June 25, 2025
⏰ Time: 1:30–3:00 PM EST
📍 Location: Zoom (register for link)
Don’t leave your regulatory journey to chance. Join us for a strategic dive into Health Canada and FDA approval processes so you can confidently navigate compliance and get your medtech product to market faster. Register your spot today!
If you have any questions, please contact the Biomedical Zone at biomedicalzone@torontomu.ca.