ISO 14971 for Medical Device Software Developers: A Practical Guide　

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Learn the essentials of ISO 14971, the international standard for medical device risk management.
This video explains key concepts of risk, safety, and practical applications—especially from the perspective of medical device software development.

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●Table of contents
01:06 Concept of Risk in ISO 14971
10:24 Concept of Safety
15:46 Overview of ISO 14971
28:07 Practical Application of RiskManagement
36:31 Concept of Safety Design
51:59 Summary

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For companies facing challenges in medical software development and regulatory compliance:
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Embedded Software Manufactory Blog (Japanese)
Articles on embedded systems and safety-critical software:
https://embeddedsoftwaremanufactory.b...

💼 Consultation & Inquiries

We support medical device manufacturers, startups, and investors with:
Regulatory compliance (FDA, IEC 62304, IEC 60601-1, cybersecurity regulations)
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👤 About Medical Software Consulting

Founder: Yoshio Sakai

With 39 years of experience at a leading medical device manufacturer, Yoshio Sakai has led software development, project management, regulatory compliance, and digital transformation initiatives. Since 2025, he has worked as an independent consultant to help medical device companies overcome software and regulatory challenges.

Books (in Japanese):

Becoming an Embedded Software Engineer Starting from Real-Time OS
https://www.amazon.co.jp/dp/4434328972/

How to Build Software That Avoids Recalls
https://www.amazon.co.jp/dp/B07VQDF47B/

Practical Guidebook to IEC 62304 (co-author)
https://www.amazon.co.jp/dp/4840748780/

👉 This channel is dedicated to explaining medical software regulations, international standards, and practical engineering methods. If your organization needs support in these areas, feel free to reach out—we are here to help.