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: th-cam.com/video/SHNFJQ_81YE/w-d-xo.html&t
Great video. One question , is it possible to combine the design transfer and the Software configuration management in one document?
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: th-cam.com/video/SHNFJQ_81YE/w-d-xo.html&t
VERY VERY interesting and useful
I'm happy you liked the content. Perhaps you also like the content presented in this webinar: th-cam.com/video/FQrjnTuE8K0/w-d-xo.html
I have a question! Can a MDSW be a device supplying energy?
Or even, active implantable? Thank you so much!
An active device can include a Software so yes a MDSW can be part os an active device.