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Master IEC 62304 – Medical Device Software Lifecycle
Learn how to develop compliant medical device software – and apply IEC 62304 in real projects
149,00€
2.5h video training 50+ pages training material 60 days access (Single license)
What you'll learn
- Understand the full IEC 62304 software lifecycle
- Learn how software development is structured for medical devices
- Apply software safety classification (Class A, B, C)
- Understand software risk management processes
- Learn software development and maintenance workflows
- Apply configuration management and change control
- Understand software problem resolution processes
- Avoid common mistakes in regulated software development
Course Preview: Get a Real Insight into the Training
Description
Software is a critical part of modern medical devices. IEC 62304 defines the required software lifecycle processes to ensure safety and regulatory compliance.
This course provides a clear and practical introduction to IEC 62304 and explains how software is developed in regulated medical environments. You will learn how development, maintenance, and risk management processes are structured to meet compliance requirements.
Instead of focusing only on theory, this course shows how software lifecycle activities are applied in real projects – including development workflows, risk management, and problem resolution.
You will also understand how IEC 62304 integrates with standards such as ISO 14971 and ISO 13485, forming the foundation for compliant medical device software development.
By the end of this course, you will be able to understand and apply IEC 62304 processes in real-world projects.
Course content
Introduction
- Introduction & Agenda
- Motivation
Basics
- Overview of IEC 62304
- Software lifecycle fundamentals
- Regulatory context
General Requirements
- Software safety classification (A, B, C)
- Documentation requirements
Software Development Process
- Planning and development workflow
- Design and implementation
- Verification activities
Software Maintenance Process
- Post-release updates
- Handling changes and updates
Software Risk Management
- Integration with ISO 14971
- Risk identification and mitigation
Software Configuration Management
- Version control
- Change management
Software Problem Resolution
- Bug tracking and resolution
- Corrective actions
Trusted by 12,000+ Engineers
From 100+ Countries
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Veselina Demireva
“The course is very structured and is based on the chapters of ISO 21434, which helped me a lot to compare the content of the course with the standard. This course is highly recommended for an initial overview of ISO. The content is clearly explained and easy to understand.”
Markus Simon
“The course has broken down a rather tough topic into a simpler words by connecting the right dots.“
Priyanka Pacharne
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Asfiyan Ali Khan
“I am coming to this program with 20+ years of experience with MIL-STD-882. This class allowed me to see what I would need to change in order to transition from 882 to ISO 26262. Overall, I thought this was a good presentation. I think the class provides a good overview for both the novice safety engineer and the old and crusty veteran. The class brought out many topics that forced me to go back to my old standard”
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Looking for a complete medical device training?
Get access to all essential medical device standards in one structured learning path – from risk management to quality and software compliance
Build a solid foundation in medical device development by combining risk management, quality management, and software standards in one training.
This bundle includes:
- ISO 14971 – Risk Management for Medical Devices
- ISO 13485 – Quality Management Systems
- IEC 62304 – Medical Device Software
Medical Devices Engineering Bundle – All Courses in One
Build a complete understanding of medical device regulations and standards – and apply them in real projects
447,00€ 249,00€
Save 44%
✔ 8+ hours of video training
✔ 200+ pages of training material
✔ 60 days access (Single license)
✔ Practical examples and real-world use cases
✔ Quizzes and structured learning path