How review medical device labeling

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In this live-streaming video, we demonstrate (live and without preparation) the review of medical device labels for compliance with US FDA requirements.

US FDA requirements for labeling are found at:

If you need help doing your own labeling review, quality system consulting, or a regulatory submission, please schedule a call with Lindsey Walker to get a consulting proposal:
  1. Medical Device Academy
  2. Medical Device Academy
  3. Labeling Requirements
  4. Labeling Review
  5. 21 CFR 801
  6. US FDA regulations
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Комментарии
Автор

You are super knowledgeable... are you able to create a video regarding medical device labeling when it comes to Country of Origin and "Made in XXX"? I think they are different but am confused. Is this required on the label or not? Then there is this component of the FTC about "Made in the USA" claims. I am confused. If you have more information, that would be super helpful.

Stwin
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Thanks for your videos, I am learning a lot!

anahanah-mb
Автор

Thanks a lot. Would you please do another video for the CE labeling requirement using an example like this one

munasofi
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Great channel and tons of info! My question is, Our company manufactures plastic parts that are components of medical devices (We do not manufacture the actual complete device). Would our company fall under/be required to have software validation for the software used to produce these components? We have been doing software validation for a while now, but im wondering if we even need to do it all together? (I also sent an email)

davidboichyn
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hey, can you hop on a call to go through a review?

StevenAnnunziata