Contract Mfg--to Manufacturer with the FDA

Melissa

Starting to get Involved
#1
I am from a Contract Manufacturer; without too many details we now may be come a Manufacturer of one of our products (that was contract before)

so going from Contract Mfg to Manufacture with the FDA and what the ramifications would be if it was changed/what are the steps?

I have been trying "google" but i found it to be of almost no help.
Thank you in Advance for your help!
 
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shimonv

Trusted Information Resource
#2
It is too big of a question for a single discussion.
I recommend that you find a consultant to help you with a gap analysis and a a quality plan for this transition.

Good luck,
Shimon
 

Melissa

Starting to get Involved
#3
This is only something that we are thinking about. If we did go forward I would hire a consultant. I was just seeing what I may be "in for" if we decide to take this route; as ultimately it will be up to me.
 

blackholequasar

The Cheerful Diabetic
#4
When the FDA is concerned, I usually find that @Watchcat is incredibly knowledgeable.

Will you be producing a finished medical device? Are you already in compliance to ISO 13485? In most cases, if you are compliant to 13485 you can very easily align with the requirements set by the FDA because they are 'mostly' harmonized. I'm the kind of person who finds standardization to be nothing but beneficial to companies. Certified or not, having structure will help you with production and quality.

If you produce a finished medical device within the US and do not comply with the FDA, there could be very serious ramifications.
 
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