Mary Beth Henderson is the VP of Regulatory Affairs and Quality Systems at inc.com/">Regulatory and Clinical Research Institute, Inc. She holds a B.A. in Chemistry from Gustavus Adolphus College, an M.S. and Ph.D. in Chemistry from Northwestern University, and an MBA from the University of Massachusetts at Lowell. Top 3 Takeaways * Mary Beth’s diverse medical device background gives her an advantage in bringing products through the FDA. * FDA regulatory plans are intricate. * Different classes of medical device have different post-approval requirements. Show Notes * [1:22] Mary Beth’s background. * [5:36] When should companies start to think about regulatory strategy? * [8:30] Basic components for developing a regulatory strategy. * [13:57] Early-stage medical device companies and use-cases. * [16:00] The differences between classes of medical device classes. * [19:55] RCRI’s expertise and offering. * [21:22] What happens after approval/clearance? * [23:25] Changes to Class II products. * [24:55] Changes to Class III products. * [26:30] The FDA’s attitude toward innovation. * [31:50] Reading on regulation. Selected Links * Overview of FDA medical device regulation * Overview of EU medical device regulation Related Podcasts * 017 – Ana Maiques * 014 – AJ Keller * 013 – Ladan Jiracek, Manfred Franke, and Doug Clinton Disclaimer: We actively write about the themes in which we invest: artificial intelligence, robotics, virtual reality, and augmented reality. From time to time, we will write about companies that are in our portfolio. Content on this site including opinions on specific themes in technology, market estimates, and estimates and commentary regarding publicly traded or private companies is not intended for use in making investment decisions. We hold no obligation to update any of our projections. We express no warranties about any estimates or opinions we make.