Webinars on Navigating MedTech Regulatory Pathway

The Biomedical Zone at TMU will be hosting two essential workshops to help you navigate regulatory and quality pathways with confidence.

Whether you're building your first device or scaling to market, these sessions are designed to equip you with the fundamentals that matter most.

🎯 What you’ll learn across both sessions:
✅ How FDA & Health Canada regulatory pathways differ and how to align your strategy
✅ Risk classification for devices and SaMD
✅ The pros and cons of MDSAP certification
✅ How to prepare for pre-submission meetings
✅ What ISO 13485 is and how to implement a QMS early
✅ Why quality is a continuous process and not a checkbox

Event Details
🔹 MedTech Regulatory Strategy: Navigating Canada & US Markets
📅 June 25, 2025
⏰ 1:30–3:00 PM EST
🔗 Register here: https://lu.ma/px3qunh1

🔹 Build a Solid Foundation: The Critical Role of ISO 13485 for MedTech Startups
📅 July 8, 2025
⏰ 1:30–3:00 PM EST
🔗 Register here: https://lu.ma/7uxp9tnh

​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.