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Medical Device Software Development Short Course

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This is a short course on medical device software development. The goal is to give you a basic understanding of some key concepts relating to the development of medical device software.

The short course is also a preview of the full online course: Introduction to Software for Medical Devices and IEC 62304 that will be available on:


00:00 Introduction
00:24 About the instructor
01:10 Who is this course for?
01:18 Learning goals
01:53 Introduction to the IEC 62304 standard
02:55 Key elements of the IEC 62304 standard
04:09 The scope of the IEC 62304 standard
07:19 Scrum (Agile) vs IEC 62304
09:14 Medical software safety classification
10:20 Medical software development planning
11:08 Documenting software development planning
13:34 What is legacy software?
14:02 How to use the legacy clause
16:41 Configuration management in software development
17:33 Version control systems
20:01 Understanding probability of occurrence of harm
22:22 Additional help and resources

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