IEC 62304 Explained: Regulatory Standard for Medical Device Software Lifecycle

Welcome to Medical Software Consulting’s channel!
In this video, we provide an easy-to-follow explanation of IEC 62304, the international standard for the software life cycle of medical devices.

You will learn:
Why IEC 62304 is essential for medical device software
How risk management and patient safety are built into the processes
Key activities such as requirements analysis, architecture design, integration testing, and system release
The connection with related standards like ISO 13485 and ISO 14971

This video is designed for engineers, QA/RA professionals, and startup teams who want to better understand global medical device software regulations.

If you find this content helpful, don’t forget to like 👍, subscribe 🔔, and share with your colleagues!
For consultation on IEC 62304 or other regulatory requirements, feel free to contact Medical Software Consulting (MSC).

●Table of contents
01:28 1. Regulatory Status of Medical Device Software
11:54 2. Why Lifecycle Management is Required for Medical Device Software
25:43 3. Overview of IEC 62304 Requirements
58:18 4. Demonstrating Compliance with IEC 62304
1:01:30 5. Summary

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📘 Additional Resources

Medical Software Consulting Portal (Japanese)
For companies facing challenges in medical software development and regulatory compliance:
https://www.medicalsoftwareconsulting...

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)
Software architecture reviews for safety and reliability
PSIRT and SBOM implementation for post-market security
Training and workshops for engineers and management teams

📩 Contact: info@medicalsoftwareconsulting.com
🌐 https://www.medicalsoftwareconsulting...

👉 Inquiries via email or social media can be handled in English.
👉 Please note that all meetings and live consultation sessions are conducted in Japanese only.

👤 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.