Guidance for 'Maintaining Compliance to 820 - FDA and ISO 13485:2003

R

race-tmt

#1
FDA and ISO 13485

Hello there!
I am new to medical devices (formally involved/educated QS-9000) and I found a thread which contained a GHTF site which is supposed to contain guidance for 'maintaining compliance to 820 and 13485 in a single QMS'. However, I was unable to access this particular information and I was wondering if anyone knows where it can be found or has a copy of it. I would appreciate it immensely!

By the way, I just wanted to let everyone know how great this forum is...it is certainly helping me make some amount of sense of this puzzle.

Thanks!
Tracey
 
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A

Aaron Lupo

#2
Tracey-

Welcome! What thread were you looking at? Were you looking for the QSIT manual?
 
R

race-tmt

#3
820-13485

:) Hi there thanks for replying.

I cannot seem to find the thread at the moment but I did print a portion of the page and it was written by Jerome Council, ASQCQA, CQA-Biomedical Auditing. Is it possible to track it by name?

Thanks so much :bigwave:
 
Last edited by a moderator:
A

Aaron Lupo

#4
Tracey-

I looked around and couldn't find anything. If you can tell me a little more about what you are looking for I (or someone else here) might have the information you are looking for.
 
R

race-tmt

#5
Thanks for looking around for me.
I am specifically looking for information regarding a way to structure and word my QMS so that it satisfies both 820 and 13485. If that is in fact possible...
I will attempt to locate the original thread in order to better explain myself.
Tracey
 
A

Aaron Lupo

#6
race-tmt said:
Thanks for looking around for me.
I am specifically looking for information regarding a way to structure and word my QMS so that it satisfies both 820 and 13485. If that is in fact possible...
I will attempt to locate the original thread in order to better explain myself.
Tracey
Ok now that I know what you are looking for that is pretty easy. Couple of questions, are you ISO certified now and I am guessing you will be looking for Certification to ISO 13485:2003? Do you have a current Quality manual I could take a look at, I can also pass along a sanatized copy of a QM that is compliant with ISO and FDA if you would like to see it.
 
R

race-tmt

#7
I found the thread. July 4th 2002 by user counj3fl
I found it by looking him up and then browsing all of his posts.

We are currently FDA compliant. Not yet ISO I am working on ISO 13485. I have written the QM and just want to figure out how to make life easier.... :vfunny:
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#9
race-tmt said:
Hello there!
I am new to medical devices (formally involved/educated QS-9000) and I found a thread which contained a GHTF site which is supposed to contain guidance for 'maintaining compliance to 820 and 13485 in a single QMS'. However, I was unable to access this particular information and I was wondering if anyone knows where it can be found or has a copy of it. I would appreciate it immensely!

By the way, I just wanted to let everyone know how great this forum is...it is certainly helping me make some amount of sense of this puzzle.

Thanks!
Tracey
I found this old document. It's aligned with the old version of 13485.
 

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