can you possibly share the original link to the FDA ESTAR Powerpoint you were using? I couldn't find it online but id love to see the entire slide presentation.
Here's a link to the eSTAR presentations we have available on UA-cam: ua-cam.com/play/PLUMSoOrFSw9feiURrdenVN4et6Df5_JLX.html. We have 60+ more that are available as part of our 510(k) course: medicaldeviceacademy.com/510k-course/
The FDA guidance is the first of its kind that I am aware of. It is only a draft at this stage, and there is no similar draft available from the MDCG for Europe.
I am really impressed with the contents you share in youtube. Thank you for updating with focus on medical device field. Best wishes for good work.
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can you possibly share the original link to the FDA ESTAR Powerpoint you were using? I couldn't find it online but id love to see the entire slide presentation.
Here's a link to the eSTAR presentations we have available on UA-cam: ua-cam.com/play/PLUMSoOrFSw9feiURrdenVN4et6Df5_JLX.html. We have 60+ more that are available as part of our 510(k) course: medicaldeviceacademy.com/510k-course/
Enlightening thank you! Any advice for AI/ML changes for Europe ? ( without official published guidances if I am right ?)
The FDA guidance is the first of its kind that I am aware of. It is only a draft at this stage, and there is no similar draft available from the MDCG for Europe.