Medical Software Consulting · Tokyo, Japan

Independent Regulatory Consultant
for Medical Device Software

Specializing in Japan's PMDA / MHLW landscape, IEC 62304, ISO 14971, IEC 81001-5-1, and SaMD cybersecurity compliance.

Greater Tokyo, Japan

39 years across software development, regulatory affairs, and cybersecurity

02 — Activities

What I do

Four overlapping areas of work — standards development, regulatory knowledge curation, Japan-market consulting, and public knowledge sharing.

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Standards Development

Member of JEITA Medical Software Committee. Contributing to IEC, ISO, AAMI, and IMDRF developments through Japan's industry committee structure.

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Regulatory Knowledge Curation

Operate MSC Regulatory Watch — a free knowledge database tracking 13 regulatory bodies. Public access since 2026.

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Japan Market Consulting

Consulting services provided exclusively to Japanese medical device companies on PMDA submissions, MHLW notifications, and software lifecycle compliance.

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Knowledge Sharing

Publish editorial commentary on regulatory developments and host explainer videos interpreting standards and guidance.

03 — Profile

Background

2025–Present

Founder & Principal Medical Software Consulting (MSC), Tokyo

2020–2025

DX Project Manager Nihon Kohden Corporation — Led business planning and project management for a medical device maintenance service DX system.

2015–2020

Cybersecurity Lead Nihon Kohden Corporation — Established internal cybersecurity standards; built compliance framework for Japan MDR Article 12-3, FDA Cybersecurity Guidance, and MHLW requirements.

2006–2015

Technical Standards & Support Nihon Kohden Corporation — Developed IEC 62304 internal standards; provided regulatory review, training, and guidance for software engineers.

1986–2006

Software Development Nihon Kohden Corporation — Developed embedded software for defibrillators and patient monitors. Managed FDA Warning Letter response and multi-country regulatory compliance (US, EU, China, Japan).

Education

B.Eng., Mathematical Engineering — College of Industrial Technology, Nihon University (1986)

Languages

Japanese (native) · English (professional working proficiency)

Memberships

JEITA Medical Software Committee — Guest member (current); Secretary 2006–2025 · GHS Health Software Promotion Council — Past Chair, Technical Education Committee (2014–2024) · SESSAME — Member (2003–present)

04 — Product

MSC Regulatory Watch

Free knowledge database

Curated regulatory intelligence
for medical device software.

A free, curated database of medical device software regulations. Tracks 13 regulatory bodies across Japan, the US, EU, and international organizations. Updated weekly via automated crawlers and manual curation. Free for individual, academic, and startup use.

13 Regulatory bodies

500+ Curated entries

Weekly Crawl frequency

Visit Regulatory Watch →

05 — Publications

Publications & activities

Books / Articles

IEC 62304 Practical Guidebook 2016 · Jiho / JEITA · WG Leader · Primary Author

Mastering Embedded Software Engineering 2006 / Updated 2023 · Nikkei BP / Seiunsha · 10,000+ copies sold

How to Build Software That Won't Be Recalled 2010 · Gijutsu-Hyohron

YouTube Channel

Medical Software Consulting Channel Explainer videos on IEC 62304, ISO 14971, and SaMD regulations. Japanese with selected English content.

Industry & Community

JEITA Medical Software Committee Guest member (current); Secretary 2006–2025

GHS Health Software Promotion Council Past Chair, Technical Education Committee (2014–2024)

SESSAME Society of Embedded Software Skill Acquisition for Managers and Engineers · Member (2003–present)

06 — Engagement

A note on engagements

Practice scope

My consulting practice focuses exclusively on the Japanese medical device industry. For inquiries about Japan-specific regulatory matters, I work primarily with companies that have operations or partnerships in Japan. For general regulatory questions or to follow my work, please connect via LinkedIn or visit MSC Regulatory Watch.

07 — Connect