020 – Mary Beth Henderson

020 – Mary Beth Henderson

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

  1. Mary Beth’s diverse medical device background gives her an advantage in bringing products through the FDA.
  2. FDA regulatory plans are intricate.
  3. 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

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