How to do Software as Medical Device Development correctly?

During this Live session, Christian Kaestner from Medical Device HQ will help us understand the best practices to develop Medical Device Software.
This session was full of questions from the audience. We will discuss IEC 62304 and the requirements.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses...
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► Links from the Video
■ Linkedin Profile Christian Kaestner: / christiankaestner
■ Medical Device HQ: medicaldevicehq.com/
■ Presentation: mailchi.mp/easymedicaldevice/...
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#easymedicaldevice #medicaldevice #compliance

[@gabrielrennes]

VERY VERY interesting and useful

[@christiankaestner6511]

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

[@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: th-cam.com/video/SHNFJQ_81YE/w-d-xo.html&t

[@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.