Designing for Commercialization: Regulatory Strategy & Design Controls

About This Session:
Bringing a medical device to market requires more than a great idea. Understanding regulatory requirements and incorporating design controls early in the development process can help innovators reduce risk and build a stronger path to commercialization.
This session will introduce the fundamentals of the FDA regulatory landscape, risk management, and design controls for medical devices. Attendees will learn how to approach documentation, verification, and quality requirements throughout the development process and how regulatory considerations can influence the design and commercialization of a health technology.
Speaker: Alexandra Smythe

About Health Tech Huddles:
The Health Tech Huddle Series is designed to provide the Penn Health-Tech community with foundational knowledge of the health tech commercialization process to supplement their engagement with Penn Health-Tech. Aligned with our goal to train the next generation of healthcare innovators, the series offers real-world insights through sessions led by industry professionals and med-tech entrepreneurs.
This event is open to Penn, Penn Medicine, and CHOP faculty, staff, and students. Please use your affiliated email address when registering to be approved.