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Notice of Speaking at MEDIC by UTokyoBD Webinar - October 29, 2026

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[Announcement]

We are pleased to announce that Minori Kosuge from our company will be speaking at the Medtech Academy Webinar "SaMD Development & Regulatory Strategy Series," hosted by MEDIC by UTokyoBD (University of Tokyo Biodesign).

  • Date & Time: Thursday, October 29, 2026, 16:00 – 17:00 (JST)
  • Theme: FDA Regulatory Trends for SaMD: Strategies for Efficient Catch-up
  • Speaker: Minori Kosuge, Head of Regulatory Affairs & Quality Assurance
  • Format: Online (Zoom Webinar) *Advance registration required

This webinar is an essential event designed to provide medical device manufacturers and startups with a realistic perspective on the development process of SaMD (Software as a Medical Device).
Kosuge will deliver a presentation titled "FDA Regulatory Trends for SaMD: Strategies for Efficient Catch-up."

As an incubation company specializing in the medical field, we provide practical, hands-on support ranging from AI and software development to final implementation.
In this seminar, she will discuss how to interpret FDA regulatory trends in SaMD development and key considerations for expanding into the U.S. market (such as preparing for FDA Pre-Submissions and understanding the regulatory gaps between Japan and the U.S.).

Advance registration is required to attend this event.
We sincerely look forward to your participation.