#Japan #Tokyo #Medical Devices #SaMD Quality #Software Regulation

Seminar on Quality Management in SaMD Startups

On October 8, we will be hosting a free seminar focusing on the complexities of quality management systems (QMS) in Software as a Medical Device (SaMD) startups. The spotlight will be on the collaboration between novices in software quality assurance and regulatory engineers, who together are building quality management frameworks for these innovative solutions.

The Relationship Between Quality Assurance and Engineers

It’s common to find a partnership between quality assurance professionals and engineers, particularly when the engineers are new to software development, and the QA professionals are unfamiliar with regulatory demands. This seminar will explore how these two groups can effectively establish a working relationship and delineate their roles.

Seminar Agenda

We have an engaging agenda lined up, covering several critical topics:
1. Common QMS Challenges for SaMD Development Newbies
2. Insights into SaMD Development Team Recruitment and Training
3. Overview of Issues Surrounding Defects, Revisions, and Recalls in Programmable Medical Devices
4. Navigating Regulatory and Practical Considerations for Software Updates

Discussions on Key Topics

1. QMS Challenges for Beginners in SaMD Development

We will address typical challenges faced by individuals new to SaMD development. A pressing question is whether non-medical or pharmaceutical engineers can learn the necessary regulations effectively. Additionally, we will discuss how quality personnel from pharmaceutical and medical device backgrounds team up to comprehend technology better.

2. SaMD Workforce Insights: Hiring Vs. Training

Is it more crucial to prioritize specialized knowledge or personal character when hiring SaMD development personnel? What level of resources is necessary at each stage of development, and should efforts be more focused on recruiting or training existing staff?

3. Realities of Defects, Revisions, and Recalls

Enter the world of programmable medical devices as we look into real-life case studies of defects and recalls. What benchmarks should businesses apply to make informed decisions?

4. Balancing Regulatory Compliance and Software Updates

How can firms ensure compliance with regulations while simultaneously rolling out software updates? We will discuss strategies for swift responses amidst regulatory requirements.

During the seminar, successful and unsuccessful case studies will be presented to further enrich our discussions. Please note that the agenda may be subject to adjustments based on the status of materials prepared and updates on essential information.

Featured Speakers

We are thrilled to welcome two distinguished speakers: Ajai RA's Ogata and Takeda from Software Regulation Co., Ltd. Mr. Ogata has an impressive background in developing CT software for multinational medical device firms and has broad experience in regulatory activities including ISO 13485 certification. Currently, he offers support in regulatory affairs for numerous medical devices as an independent consultant.

Mr. Takeda has also made significant contributions to the field, having managed regulatory affairs for therapeutic applications while at CureApp, Japan’s first treatment app for smoking cessation and high blood pressure. After his tenure at CureApp, he went on to establish Software Regulation, where he continues to aid businesses in navigating the regulatory landscape for medical devices, including AI/ML diagnostic applications.

Who Should Attend?

This seminar is perfect for:

• - Those interested in starting or joining deep-tech startups
• - Individuals eager to learn about the cutting-edge solutions in the medical field
• - Professionals in digital healthcare
• - Those involved in the regulatory aspects, strategy, or R&D in life sciences
• - Startup founders and executives

Event Details

• - Date: October 8, 2025 (Wednesday)
• - Time: 18:00 - 19:15
• - Location: Fabbit Aoyama & Online (Google Meet)
• - Cost: Free

Please be aware that participation may be limited based on registration circumstances. We kindly ask that representatives from competing companies refrain from attending for promotional purposes. Materials will not be distributed.

Schedule

Common to both Online and Offline Sessions

• - 18:00 - 18:05: Introduction
• - 18:05 - 18:45: Seminar Presentation
• - 18:45 - 19:15: Q&A Session / Discussion

Offline Attendees Only

• - 19:15 - 20:00: Networking and Recent Regulatory Updates

About the Speakers

1. Ogata from Ajai RA:
With extensive experience in medical software development and regulatory affairs across various high-tech medical companies, Mr. Ogata has been involved in overseeing regulatory processes for numerous medical devices, managing complex QMS tasks, and supporting over 20 regulatory submissions.

2. Takeda from Software Regulation:
Mr. Takeda spearheaded the regulatory submissions for CureApp’s therapeutic apps, and founded Software Regulation to extend support to companies navigating regulatory compliance within SaMD.
Visit Software Regulation

Stay tuned for what promises to be an enriching and informative seminar about SaMD quality management. We look forward to your participation!