IEC 62304 Essential Overview | Medical Device Software Explained
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Thank you for watching this video from Medical Software Consulting.
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This video provides an essential overview of IEC 62304, the international standard for the software life cycle of medical devices.
In about 15 minutes, you will learn:
・What IEC 62304 covers
・Why it is critical for medical device safety and compliance
・How it applies to software development and maintenance
Whether you are a software engineer, QA/RA professional, or startup founder, this guide will help you understand the fundamentals of IEC 62304.
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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
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Practical Guidebook to IEC 62304 (co-author)
https://www.amazon.co.jp/dp/4840748780/
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