Medical Device Software Development Short Course

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.

Don't miss checking out the online course Introduction to SaMD and IEC 82304-1:

Starting October 2023, the templates mentioned in the video are no longer available for free on Medical Device HQ. However, more comprehensive paid versions are now accessible via this link:
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Chapters:
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

[christiankaestner]

Thank you to all viewers and likers of this video - much appreciated!! What would you like to know more about when working with medical device software? Please leave your suggestions below and remember to subscribe for upcoming videos!

[mrugeshpatel]

Hello i am a biomedical engineering student in india this video was helpful for me for my project work thank you 😊

[lukaspetrikas]

But how do you get approved for IEC 62304. You have mentioned a few things that must be done regarding version control, documentation and etc. Do you have to provide the source code to whoever is issuing the certificates for them to analyze everything in order to confirm that you are fully compliant?

[mahesha]

Please provide Quality Assurance Engineer roles and responsibilities in medical device

[bmistry]

@MedicalDeviceHQ Does the battery powered medical device need to comply this standard for the MCU firmware (baremetal and not OS) or its applicable to PC based software with OS?

[ashbird]

What are the challenges you will faceduring development of Software as a medical device? How ill you overcome the challenges?