Can you give us an example "software compliance tool" that was used to help in IEC62304 compliance? It could be more than one, but I need actual product names
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
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.
@@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!
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?
Can you give us an example "software compliance tool" that was used to help in IEC62304 compliance? It could be more than one, but I need actual product names
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
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.
@@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!
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?
An SCA tool (Software Component Analysis) comes to mind
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