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The short course is also a preview of the full online course: Introduction to Software for Medical Devices and IEC 62304 which will be available at: https://medicaldevicehq.com/iec62304
Don't miss the Introduction to SaMD and IEC 82304-1 online course:
https://medicaldevicehq.com/introduction-to-samd-iec62304-and-iec-82304-1-online-course/
As of October 2023, the templates mentioned in the video will no longer be available for free on Medical Device HQ. However, more extensive paid versions can now be accessed via this link:
https://medicaldevicehq.com/templates/.
We offer free premium templates to our newsletter subscribers. Upon registration you will receive immediate access to some templates. Others will be distributed periodically as part of our newsletter email campaigns.
Chapters:
00:00 Introduction
00:24 About the instructor
01:10 Who is this course intended for?
01:18 Learning objectives
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 Security classification of medical software
10:20 Planning for medical software development
11:08 Documenting the software development planning
13:34 What is legacy software?
14:02 How to use the old clause
16:41 Configuration management in software development
17:33 Version control systems
20:01 Understanding the likelihood of damage
22:22 Extra help and resources
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