Free Seminar on July 17: Practical Guide to Business Licensing and QMS Compliance for Medical Devices

Berry Inc. (Headquarters: Taito-ku, Tokyo; CEO: Yuji Nakano) will host a free online seminar titled "Practical Guide to Business Licensing and QMS Compliance for Medical Devices – Key Points for Startups and New Market Entrants" on Friday, July 17, 2026, from 14:00 to 15:30.

The seminar will feature Tomoki Hasegawa (Office Hasegawa LLC), a regulatory consultant with extensive experience in regulatory affairs, quality assurance, business licensing, and ISO 13485 coordination at multinational medical device and IVD manufacturers. He will provide a comprehensive, step-by-step explanation of the entire process—from obtaining business licenses to QMS operation and compliance audit preparation.

[Common Challenges When Entering the Medical Device Business]

Companies entering the medical device and in vitro diagnostic (IVD) pharmaceutical business often face the following challenges:

- Wanting to enter the medical device business but lacking a clear understanding of the required business licenses - Unable to determine which licenses (e.g., manufacturing and marketing, manufacturing, repair, sales/leasing) are necessary for their business - Unclear about the application process, required documents, and best practices for interacting with regulatory authorities - Concerned about whether their QMS meets the requirements of the QMS Ordinance and whether they can pass compliance inspections - Struggling to prioritize actions due to limited resources

[Background and Objectives of the Seminar]

To launch a business in medical devices or IVDs, companies must obtain business licenses under the Pharmaceutical Affairs Law and establish and operate a Quality Management System (QMS) compliant with the QMS Ordinance. However, the licensing framework is complex, and the application process involves unique procedures. Startups and new entrants often struggle with knowing where to begin.

This seminar will systematically explain the entire workflow—from license acquisition to QMS operation and audit preparation. Practical insights, real-world examples, common pitfalls, and mitigation strategies will be shared to help participants immediately apply the knowledge to their operations.

[Event Overview]

- Date and Time: July 17, 2026 (Fri), 14:00–15:30 - Format: Online (via Zoom) - Target Audience: QMS officers, quality assurance teams, manufacturing managers, responsible engineers, executives, and others - Organizer: Berry Inc. - Fee: Free (prior registration required)

[Seminar Agenda]

Part 1: "Practical Aspects of Business Licensing and QMS Compliance"

Speaker: Tomoki Hasegawa, Representative Member, Office Hasegawa LLC

This session will cover the framework of required business licenses for medical devices and IVDs, practical application procedures, fundamental requirements of the QMS Ordinance, key points for compliance audits, and common challenges and solutions for startups and new entrants, illustrated with real-world examples.

Part 2: "Introduction to QMSmart Solution"

Speaker: Yuji Nakano, CEO, Berry Inc.

An overview and case studies of QMSmart, a cloud-based eQMS platform. The session will demonstrate how QMSmart centralizes QMS tasks such as document management, quality event management (CAPA), and training, and enhances efficiency through AI-powered regulatory compliance checks and root cause analysis.

Part 3: "Q&A Session"

Questions will be collected during the webinar.

* The session may be extended depending on the number of questions.

[Speaker Profile]

Tomoki Hasegawa (Office Hasegawa LLC, Representative Member)

Graduated from Gifu Pharmaceutical University and completed the Professional Graduate School at Tokyo University of Science. He has held various roles in regulatory affairs, quality assurance, quality control, safety management, business licensing, and ISO 13485 coordination at multiple multinational medical device and IVD manufacturers. He later led the establishment of the clinical trial management division at a foreign regulatory consulting firm. He now runs Office Hasegawa LLC, providing broad support for regulatory and quality system development for medical device and IVD manufacturers.

Lecturer at the Fuji Mountain Medical Device Development Engineer Training Program (F-met). Former member of the RAQA Committee at AMDD (U.S. Medical Device & IVD Industry Group) and former Executive and Education Committee member at RAPS (Regulatory Affairs Professional Society) Japan.

[Registration]

Please register in advance via the seminar’s dedicated webpage:

https://yakuji-navi.com/seminars/4unazlu-l

[About Berry Inc.]

Berry Inc. is a medical device startup founded in 2021. Guided by the mission of "realizing a society where everyone can access necessary medical care when needed," the company manufactures and sells BabyBand, a 3D-printed cranial remolding helmet for infants, leveraging 3D printing technology and 3D data analytics.

As of June 2026, BabyBand has been introduced to over 270 medical institutions nationwide. Drawing on expertise accumulated through in-house development and manufacturing, Berry is also addressing broader challenges in the medical device industry.

The company is certified under the Medical Device Quality Management System standard ISO 13485:2016 and the Information Security standard ISO/IEC 27001:2022 (ISMS). It has built a reliable system for delivering medical devices, focusing on quality, safety, and information management.

- Founded: July 2021 - Headquarters: 4F, Sumitomo Realty Ueno Okachimachi Building, 3-7-1 Motoasakusa, Taito-ku, Tokyo - CEO: Yuji Nakano - Business: Manufacturing and marketing of medical devices / Software design and development - Corporate Website: https://www.berryinc.co.jp/ - Yakuji Navi: https://yakuji-navi.com/ - QMSmart: https://service.qm-smart.com/