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IVF medical devices standards and test methods

S

Samarta

#1
Hi All

I intend to develop an "embryo transfer catheter" and manufacture it. As FDA prescribed, the device must undergo some testings like:
*mouse embryo assay (MEA)​
*endotoxin testing (LAL)​
*biocompatibility testing​
*clinical testing​
*and so on​
(the whole regulations of this device is accessible in the "code of federal regulations title21" through §884.6110 )​
Now the question: Where can i find the comprehensive protocol of each testing, for example what are the clinical testing items and MEA procedure?

Thanks for your time
 
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indubioush

Quite Involved in Discussions
#2
You won't find a comprehensive protocol for tests such as these. It sounds like the medical device world is very new to you. Believe me, this world is large and complicated, and you will need specialized people who have gone through this before to guide you.
 
S

Samarta

#4
You won't find a comprehensive protocol for tests such as these. It sounds like the medical device world is very new to you. Believe me, this world is large and complicated, and you will need specialized people who have gone through this before to guide you.
Would you please introduce someone in this forum to guide me a little more on this specific topic?
 

chris1price

Trusted Information Resource
#5
I would start by searching US pharmacopeia and ISO standards, you will probably find most of your answers there. Otherwise talk to an appropriate test laboratory
 
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