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Ask the Experts Session: Rapid Design & Development in Highly Regulated Environment

Eri Hirumi  (Regulatory Affairs Specialist, Microvention)

Location: 160A

Date: Thursday, May 7

Time: 10:30am - 10:30am

Track: Track C: Surviving the Changing Regulatory Environment & Rising Costs

Vault Recording: TBD

The current industry landscape for innovative medical devices has become more competitive and challenging in recent years, with new significant regulatory hurdles to jump through. Proper collaboration between companies and regulatory bodies is more crucial for development than ever before. During this interactive session, two experts will go into a short discussion on how to bridge the growing gap between innovator and regulator, and then open the floor to the audience for an extended Q&A session. In this format, the experts will encourage comments, insights or questions from attendees to engage in a collaborative discussion. Join this gathering to hear from your peers, learn from experts, and accelerate the rate at which your innovations are available to the public. Topics will include:

  • How regulatory bodies help alleviate this growing gap
  • How medical device companies can best plan for compliance