Mary Beth Henderson is the VP of Regulatory Affairs and Quality Systems at 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.
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