How mislabeling can sink your Medtech ship (and what to do about it)
In the medtech space, product labeling is far more than a regulatory requirement—it’s a key factor in product success. Labels are how you communicate critical information about your product’s purpose, safety, and proper use to both regulators and end-users. When handled incorrectly, mislabeling can lead to costly consequences, from delayed approvals and heightened regulatory scrutiny to enforcement actions that may jeopardize your market entry or company reputation.
What You’ll Learn
This masterclass will guide you through key areas of medical product labeling, with practical advice you can implement right away:
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Labeling controls 101: Understand the foundational principles of labeling regulations, including Health Canada and FDA expectations for medical devices and therapeutic products.
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Real-world risks of mislabeling: Hear examples of how unclear or non-compliant labeling has derailed products, and how these risks can be mitigated with the right systems and documentation in place.
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Implementing strong labeling practices early: Learn why labeling must be treated as a core part of product development, not an afterthought, and how to build scalable processes that grow with your company.
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Navigating global regulatory expectations: Get insights into managing labeling requirements across multiple jurisdictions and how to avoid compliance issues when expanding internationally.
Who should attend
This expert-led session is designed specifically for medical device, biotech, and pharma innovators. You’ll gain a comprehensive understanding of labeling best practices, common pitfalls to avoid, and why establishing clear, compliant labeling processes early in product development is essential for long-term success.
Accessibility
This event will be held virtually with closed captioning available. For additional accommodations, please contact info@innovationfactory.ca.
Meet the experts
Gordon Wehner, President at QualMed and Expert Advisor – Regulatory at Innovation Factory
Gordon Wehner is an Expert Advisor at Innovation Factory who brings extensive experience in guiding innovative medical organizations toward the implementation of effective quality management systems and navigating international medical device regulatory requirements. With 39 years of experience in Quality Management and Regulatory Affairs, Gordon continually demonstrates cross-disciplined talents in problem-solving for complex issues in both mature and start-up organizations in the medical device industry.
Dylan Horvath, Founder & CEO of Cortex Design
Dylan holds a degree in Systems Design Engineering from the University of Waterloo, class of 1997. He founded Cortex Design in 1999 to create impactful designed experiences that substantially improve human quality of life.
In his time growing Cortex into a leading ISO-13485:2016 medical device design and production company within Canada, Dylan has worn almost every hat in the organization — from industrial designer to embedded systems engineer to mechatronics designer to international production liaison on dozens of overseas production visits.
Today, Dylan provides leadership and coaching to the team, sets strategic objectives, and provides a positive work culture within which the staff can succeed. Through coaching, mentorship and guidance, Dylan is accountable for delivering great project outcomes to clients.
In addition to leading Cortex, Dylan is the co-president of the Association of Canadian Industrial Designers, the Vice President of the Association of Chartered Industrial Designers of Ontario, and a regular speaker at events where he advocates for the power of design to expand human capability.
- May 15 2025
- Expired!
- 1:00 pm - 2:00 pm
