Dates
Are you a medical device startup founder looking to fast-track your growth and navigate the regulatory landscape with ease? Join us for an insightful Lunch & Learn with industry expert Hasnaa Fatehi, where you'll discover how prioritizing regulatory compliance from the start can set your MedTech business up for long-term success.
In this session, Hasnaa will introduce three major regulatory frameworks: Health Canada, the US FDA, and EU CE marking. Learn how to align your startup’s strategy with these regulations to avoid costly delays, build investor confidence, and gain quicker access to global markets. This talk will provide practical tips on how to effectively manage limited resources while navigating regulatory hurdles, turning compliance into a growth driver, rather than an obstacle.
Key Takeaways:
- The importance of regulatory compliance in MedTech startups
- Understanding major regulatory frameworks (Health Canada, FDA, EU CE marking)
- Strategies for integrating compliance into your business early
- Practical tips for resource management and risk reduction
About the Speaker:
Hasnaa Fatehi holds an MSc in Biomedical Engineering from the University of Grenoble Alpes in France and a PhD in Systems Biology from Goethe University Frankfurt in Germany. She is a certified MedTech regulatory affairs and quality assurance professional with over 15 years of industry experience, with unmatched work across Asia, Europe, and North America.
Hasnaa is the founder and CEO of QARALOGIC, a boutique consultancy focused on helping MedTech leaders bring safe and effective devices to market, while decreasing their overall compliance costs and time to market.
Hasnaa is currently the chair of the Regulatory Affairs Professionals Society (RAPS) Western Canada Chapter, the largest organization of Regulatory professionals. She is also the founder of the not-for-profit Western Canada MedTech Network, which brings together the Western Canada MedTech ecosystem to learn, share ideas, and connect to one another.
Finally, she is an avid proponent of EDI&B in the MedTech industry and a "re-imaginer" of the industry as a whole. You are welcome to connect with Hasnaa on LinkedIn or schedule a call by visiting www.qaralogic.com.
Agenda:
12:00 PM – Arrival and Lunch
12:15 PM – Presentation by Hasnaa Fatehi
1:00 PM – Q&A Session
1:15 PM – Networking
This is a free event but spots are limited! Be sure to register to secure your place and enjoy a complimentary lunch while learning valuable insights for your MedTech startup.
About BioNext:
BioNext is a MedTech incubator designed to accelerate the translation of early ideas into commercial innovations. Offering a network of core facilities and access to dedicated infrastructure, BioNext supports entrepreneurs and innovators in developing new technologies and navigating the complex paths to commercialization.
About Western Research Parks:
Western Research Parks is a dynamic innovation hub that bridges the gap between research and industry. With a focus on driving innovation and growth, Western Research Parks provide cutting-edge laboratories, coworking spaces, and flexible office rentals for businesses looking to scale and make an impact globally. Located in London, Ontario, Western Research Parks offer access to Western University’s research expertise, a diverse talent pool, and a thriving ecosystem of entrepreneurs, startups, and established companies.
We look forward to seeing you there!
Hosted by:
Western Research Parks & BioNext
Date and Time:
Tuesday, October 22, 2024
12:00 PM - 2:00 PM EDT
Location:
The Connector Suites, Convergence Centre, Western Research Parks
999 Collip Circle, London, ON
