Free Event: Deep Dive into SaMD Cybersecurity Review Trends

We are hosting a free event on SaMD cybersecurity starting at 18:00 on Wednesday, June 24, 2026.

The event will be held in a hybrid format, both online and offline (near Nihonbashi, Chuo City, Tokyo).

Online access will be partially available.

Overview

This event will cover the following topics related to cybersecurity for software as a medical device (SaMD):

- Fundamental knowledge of SaMD cybersecurity

- Overview of SaMD cybersecurity topics and trends in regulatory review feedback

At the physical venue only, we will conduct case studies on actual review feedback related to SaMD cybersecurity and delve deeper into regulatory authorities’ perspectives through discussion.

For this event, we are honored to welcome Mr. Takeshi Ogata of Ajai RA, who has extensive hands-on experience across development and quality assurance in numerous SaMD startups, and has been involved in regulatory affairs and business development for AI, DTx, and VR medical devices.

Together with Mr. Eiji Takeda, CEO of Software Regulation Co., Ltd., who will moderate the session, we will discuss SaMD cybersecurity from practical implementation insights to the latest regulatory topics.

Please note that the content, speakers, and schedule are subject to change without prior notice.

This event is free of charge and will be conducted in a hybrid format.

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Date and Venue

Date and Time

Wednesday, June 24, 2026, 18:00–19:00 (partial online access)

Venue

On-site venue

Near Nihonbashi, Chuo City, Tokyo (exact location to be provided by the day before the event)

Online

URL will be sent to those who register in advance

Admission Fee

Free

Organizer

Software Regulation

Program Overview

[For both online and offline participants]

18:00 – 18:05

Introduction

18:05 – 18:20

Fundamentals of SaMD Cybersecurity

18:20 – 18:30

Overview of SaMD Cybersecurity Topics

[Offline only]

18:30 – 18:45

Recent Topics & Q&A

18:45 – 19:00

Networking

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Speakers and Panelists

Takeshi Ogata, Ajai RA

Formerly involved in CT development at GE Healthcare Systems Co., Ltd., serving as Software Engineering Manager and Principal Engineer. Transitioned into the software medical device field, contributing to regulatory affairs and business development at Elpixel Inc., CureApp Inc., and Holoeyes Inc. for AI, DTx, and VR medical devices. As a sole proprietor, has provided regulatory support to over 30 companies.

Eiji Takeda, Representative Director, Software Regulation Co., Ltd.

Has experience leading regulatory submissions for Japan’s first therapeutic app at a startup. After leaving CureApp, founded a company dedicated to supporting regulatory submissions for SaMD, providing comprehensive regulatory support both domestically and internationally for companies developing therapeutic apps and diagnostic AI software.

Call for Pre-submitted Questions

Registration for this event requires submission of a pre-event question. Please complete the form field. Selected questions will be addressed during the session.

Additionally, live questions will be accepted via online tools during the event.

* Due to time constraints, we may not be able to answer all questions. Thank you for your understanding.

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