How to find a good 510(k) submission training?

lyannastark

Starting to get Involved
#1
I’m looking for a good training for 510(k) submission. Can be online but if it’s in Europe, it can be on-site as well. Are there any recommendations?

Thanks!
 
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monoj mon

Trusted Information Resource
#2
If you are just checking resources for learning purposes then have you checked CDRH Learn Website! It was very helpful for me when I was learning to prepare a 510(k) submission.

If you are checking for training courses for your internal record then I am not sure about any particular one. I got all my early knowledges by reading blogs, watching videos and talking to our consultant.
 

Watchcat

Trusted Information Resource
#3
You might try:
FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

Keep in mind that there is a big difference between "preparing" (aka "compiling") and "doing" a 510(k). The latter involves figuring out what you need to put together a 510(k) and getting it together. Once you have everything you need, "preparing" a 510(k) is a fairly simple exercise, although an RA professional can often prepare one that is much more "reviewable" than a DIYer, reducing the number of deficiencies that FDA will issue as a convenient alternative to spending its limited review time struggling to understand your submission, or hunt for key parts of it.
 
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