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Biomedevice Boston 2020 Presentation Store

Welcome to the Biomedevice Boston Presentation Store. Here you can view and download conference presentations before, during, and after the event, as well as free content from the Center Stage. If you’re looking for a presentation from a specific session, go to that session, and if we have the presentation to share, you’ll see the file below the session description. If you are unable to find it here, it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

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

Eri Hirumi  (Regulatory Affairs Specialist, Microvention)

Laura Jeannel  (Senior Technical Specialist, Meridian BioGroup)

Location: Biomed Room 1

Date: Thursday, September 17

Time: 9:30am - 10:15am

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 the ever-impending 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 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 include:
  • How the rate of approval by FDA of medical devices has changed in an era of Covid-19 with the EUA designation
  • Steps for developing innovative and efficient regulatory strategies and plans
  • A timeline and checklist for developing your strategy