How to do Software as Medical Device Development correctly?

[@yannickmoukamtchokote7670]

Great video. One question , is it possible to combine the design transfer and the Software configuration management in one document?

[@christiankaestner6511]

You are always free to combine information as you find it meaningful. The challenge you might face is that auditors might look for specific documents, but it shouldn't be a problem if you explain your approach. You might find this video helpful, where I'm talking about documenting compliance with IEC 62304: kzbin.info/www/bejne/iXmxd32HlJ1kj6c&t

[@gabrielrennes]

VERY VERY interesting and useful

[@christiankaestner6511]

I'm happy you liked the content. Perhaps you also like the content presented in this webinar: kzbin.info/www/bejne/fILVm6GKqqprgZI

[@adalid500xd]

I have a question! Can a MDSW be a device supplying energy?

[@adalid500xd]

Or even, active implantable? Thank you so much!

[@EasyMedicalDevice]

An active device can include a Software so yes a MDSW can be part os an active device.