13485cert

GHTF Just Released New and Updated Documents

In GHTF on November 8, 2012 at 6:38 pm

GHTF Just Released New & Updated Documents.

Leonard Eisner recently posted these links to new guidance documents that were released on November 2, 2012 by GHTF. These are definitely worth reading and downloading for your external Standards library.

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  1. I have been reading through your blog posts.. I work for a small company producing medical software, and it has been really helpful to get information regarding the various hoops we need to jump through. I have a question regarding a guest post you did on another site (I am commenting on this blog, because I can’t comment on that one w/o a wordpress login). The blog was http://www.creoquality.com/2012/07/fda-510k-or-ce-marking/. This was the first time I came across the Quality Management System stuff… I have been looking into it, and it is extremely confusing. Do you have any leads for good guidance sites on this?? (Sorry for posting here.. if you have a general comment area, or contact spot, I could not find it!). Thanks!

    • Hi Erica,

      Thank you for your questions Erica. In order to leave a comment on a WordPress Blog you need to be logged in, but you don’t necessarily have to make any postings of your own and the accounts are free. I also have my own website (http://www.13485cert.com/) where you can leave a message on the contact us page. This was fine too!

      As for getting good guidance on Quality Management System (QMS) Stuff, there are a very large number of excellent sources. I will provide a list as a new blog posting with the links for you to follow.

      Rob

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