Suggestions for FDA compliant QA procedure for invitrodiagnostic device?

N

niksam

#1
could someone guide me on QA procedure for invitrodiagnostic device that complies with FDA regulation
 
Elsmar Forum Sponsor
N

niksam

#4
Hi Wes

the company i work for is just into phase II trial and in the process of preparing a pre-IDE with FDA, we do have accrediation for ISO-9001 and are in the process of going in for ISO13485, so i would like inputs on QA requirements to comply with FDA , i have gone through 21CFR820, 812, but still am not clear where to get started.
 

Al Rosen

Staff member
Super Moderator
#5
The requirements are in 21cfr820. I know there have been comparisons posted here in the cove between quality system requirements. Use one of them to see where you fall short. Look in the post attachments list.
 
N

niksam

#6
Hi Al

Sorry if u think it as a stupid query,as i am new to this forum, what do you mean by post attachment list
 

Jim Wynne

Staff member
Admin
#7
Hi Al

Sorry if u think it as a stupid query,as i am new to this forum, what do you mean by post attachment list
Don't worry, it's not a stupid question. Go to the top of this page and click on "Post Attachments List." From the resulting page you can search for what you're looking for.
 
N

niksam

#9
HI Al

I have just viewed the 8 device master records you had suggested on 15th nov on a different thread, i will have a look at it in detail and get back!
 
N

niksam

#10
our company is presently entering phase II trial, and what i require is a QA sop for clinical investigator, kind of check list of all requirements to comply with FDA and ICH-GCP guidelines, we have not yet reached the manufacturing stage, and 21CFR820 mainly gives provisions on those lines.we are looking into design control, and risk management , but what i really need is guidance on QA procedures
 
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