How review medical device labeling

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:
➤ www.ecfr.gov/current/title-21...
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:
➤ calendly.com/sales-lindsey

[@munasofi5037]

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

[@MedicalDeviceAcademy]

I will consider your request. It might be a few months, but I'm sure one of our CE Marking clients will give me spark of an idea for this.

[@anapaulahubli]

Thanks for your videos, I am learning a lot!

[@MedicalDeviceAcademy]

You are welcome! Any suggestions for the next live-streaming?

[@anapaulahubli]

Uh, there are some topics, I don't know if you have already spoken about it: Quality Management: SPC . Also: Dealing with non-confom materials, or CAPAs. Sterilized devices....
😅

[@davidboichyn3596]

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)

[@MedicalDeviceAcademy]

The FDA requires that automated processes be validated in accordance with 21 CFR 820.75. This would include the software that runs the equipment. This type of software is different from software in a medical device (SiMD) or software as a medical device (SaMD). For those two types of devices, software validation is explained in IEC 62304-1 and IEC/TR 80002-1. For software used in the quality system, the applicable standard is IEC/TR 80002-2.

[@user-yp3ht1fe6o]

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

[@MedicalDeviceAcademy]

If companies need help with a labeling review, they only need to schedule a call with me: calendly.com/13485cert/30min