FDA regulations for medical devices distributor in US

[inquisit]

Hi , I'm a QA in medical device agent. I am currently wtiting a Quality manual which would be related to 21 CFR 820 in FDA. Is there a checlist I can follow & keep in mind?
I am completely new to this field of Quality & fda, so the simplest of information , any guiselines would be much appreciated.
Thanks

[GStough]

In Reply to Parent Post by inquisit

Hi , I'm a QA in medical device agent. I am currently wtiting a Quality manual which would be related to 21 CFR 820 in FDA. Is there a checlist I can follow & keep in mind?
I am completely new to this field of Quality & fda, so the simplest of information , any guiselines would be much appreciated.
Thanks

There are some checklists that you might find helpful in the Post Attachments List (thin green bar in the upper left corner of this page). Here are a couple....

http://elsmar.com/Forums/attachment....achmentid=2557
http://elsmar.com/Forums/attachment....achmentid=8754

[inquisit]

That's a good start & lot of information to go through. I guess I'm on my way now.
Thanks a lot. I"ll probably have more questions later.