We are delighted to announce that Joel Ironstone will be speaking at our Medical Device Quality Assurance and Regulatory Affairs Conference on October 8-9 in Stockholm, Sweden!
Joel Ironstone is a medical technology development expert with over 25 years of experience developing novel medical technologies. His experience includes technical development, regulatory approvals and the design and execution of first-in-human and pivotal clinical trials. He has brought more than a dozen innovative healthcare products from concept through to commercialization, and has held executive positions as CEO, COO, VP Product Development, and VP Clinical and Regulatory Affairs. Joel has been providing strategic regulatory and product development consulting support to medical device companies across many therapeutic areas and has led numerous successful FDA submissions for products of all classes. He is currently Vice President at Avania.
In his session, “How to Cross the Atlantic: Adapting European Expertise for U.S. Regulatory Success,” Joel will cover:
◾ Classification and Regulatory Pathways in the U.S. (and how they differ from Europe)
◾ Overview of the 510(k), De-Novo, and PMA processes
◾ More on the 510(k) Process—Demonstrating Substantial Equivalence
◾ When and how to talk to the FDA
◾ Other programs (Breakthrough Designation, SteP, HUD)
◾ Key differences in evidence required for U.S. vs. EU, including clinical evidence and biocompatibility
This is a unique opportunity to gain valuable insights from a top expert in the field.
📅 Date: October 8-9, 2024
📍 Location: Stockholm, Sweden
Don’t miss out on this chance to learn from one of the leading authorities in medical technology!