Participation in Networking and Free General Consultation Session with Medical Device Experts @ Yokohama

Date & Time: Thursday, June 12, 2025　13:00–17:30　　

Venue: Pacifico Yokohama, Exhibition Hall A　　 (1-1-1 Minatomirai, Kohoku-ku, Yokohama, Kanagawa)

Our Regulatory Affairs and Quality Assurance team member, Minori Kosuge, will be participating as a consultant in the "Networking and Free General Consultation Session with Medical Device Experts",　　 held as part of the co-located events at the 100th Annual Meeting of the Japanese Society for Medical Instrumentation (JSMI): "Medical Show Japan & Business Expo 2025."

We will be offering practical advice on regulatory affairs and quality assurance, tailored to companies with in-house development departments—from establishing quality systems and development processes required for medical device approval, to preparing regulatory submissions.　　

In particular, we specialize in providing guidance related to:

• ISO 13485 (Quality Management Systems)
• ISO 14971 (Risk Management for Medical Devices)
• IEC 62304 (Software Development Lifecycle Processes)
• IEC 81001-5-1 (Cybersecurity in Health Software)

We are also open to inquiries outside of these topics depending on the content, so please feel free to stop by for a consultation.

Register here: https://business.form-mailer.jp/fms/f189c2d1290035　　

Note: While the consultation sessions are held over three days, Minori Kosuge is scheduled to participate on June 12 only.

(Please note that this may be subject to change before the event. To ensure a chance to speak with her, we kindly ask that you make a reservation in advance.)

For more details about the exhibition: https://www.ikou-commons.com/t_info/exhibition/jsmi100/ikou-commons.com