Documenting compliance with IEC 62304 in medical device software development
Ғылым және технология
Ever had problems with compliance to IEC 62304? Do you want to apply Agile development principles such as SCRUM when working with medical device software? No problem! In this video, Christian Kaestner will explain how you can work the way you want and document how it is compliant with IEC 62304.
If you are into Agile development, you will also get a teaser from AAMI TIR 45, which is about “Guidance on the use of AGILE practices in the development of medical device software”.
This is an excerpt from the course "Introduction to Software for Medical Devices and IEC 62304" which is available at: medicaldevicehq.com/iec62304
Read more about documenting compliance with IEC 62304 and working with Agile here:
medicaldevicehq.com/iec-62304...
Don't miss checking out the online course Introduction to SaMD and IEC 82304-1:
medicaldevicehq.com/introduct...
Chapters:
0:00 Introduction
0:23 About the instructor
0:40 Meeting the requirements of IEC 62304
1:25 Compliance checklist
2:25 Software development processes
5:04 Different development methods
5:52 Standard requirements
6:45 Verification of requirements of the standard
7:46 Scrum and waterfall
9:53 AAMI technical report
11:48 Additional resources
Пікірлер: 5
Great video, thanks for this. What is your recommendation for documenting deep dependencies for SOUP? For the high level languages, a library could have hundred other libraries as deep dependency, would regulators care for those or could just document the first level dependency and justify why we haven't documented the deeps?
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Hello, can you also do a quick comparison on how the product development cycle between mechanical, SW, electromechanical and embedded SW medical device map and differ
@christiankaestner6511
2 жыл бұрын
Thank you for your suggestion! However, a short response on this topic might give you some directions. In my opinion, the main difference between software development and other technologies is the emphasis on a solid development process when developing SW. This is because you can achieve much better test coverage on electronics and mechanics compared to what is ever possible with software.
@mayankkakkar2945
2 жыл бұрын
@@christiankaestner6511 Thanks for providing a good starting point Christian! I am taking your 62304 course at MedicaldeviceHQ and adding a short chapter on this maybe a great help, for all who work at large corporations and might be involved with different project types from time to time. Thanks again!