Build a Solid Foundation: ISO 13485 for MedTech Innovators
🔧 Workshop Overview
Build a Solid Foundation: The Critical Role of ISO 13485 for MedTech Innovators
In the highly regulated medical device industry, a strong Quality Management System (QMS) is essential, not just for compliance, but for building trust, ensuring patient safety, and accelerating your path to market. This workshop provides an introduction to ISO 13485 and practical strategies for implementation, helping startups embed quality into every stage of product
development.
📚 Learning Outcomes
By the end of this session, participants will:
ISO 13485 Overview: Understand the core principles, structure, and significance of ISO 13485 in medical device development
QMS Implementation: Explore the basic steps for building your QMS from DIY approaches to software solutions
Design & Development Integration: Learn how quality requirements apply across the product lifecycle and how early adoption reduces compliance risks
Audit & Improvement Cycle: Gain insight into the continuous nature of ISO 13485 compliance through internal and certification audits and ongoing process improvement
This session is perfect for clinicians, researchers, founders, and students developing medtech solutions or working within the ecosystem who need a clear understanding of quality systems.
👩🏫 About the Speaker
Daniella Marx is a Regulatory Affairs and Quality Management Consultant with expertise in medical device quality systems, risk management, and international regulatory strategy. She holds a PhD in Biomedical Engineering from Toronto Metropolitan University and is currently a Project Manager at Docusys Corporation. Daniella supports medtech companies in navigating Health Canada, FDA, and EU regulatory frameworks, specializing in QMS implementation, SOP development, and MDSAP certification.
Workshop Details
📅 Date: July 8, 2025
⏰ Time: 1:30–3:00 PM EST
📍 Location: Zoom (register for link)
Don’t let quality management be an afterthought. Join us to learn how ISO 13485 can become the backbone of your medtech startup’s success. Register now and start building a system that grows with your company.
If you have any questions, please contact the Biomedical Zone at biomedicalzone@torontomu.ca.