Learning ISO 13485 - Getting a better understanding of the requirements

M

moocow

#1
I just began working for a medical device company in the US, and am wondering is there anything that will help me getting a better understanding of the requirements. I've never worked with it before and need some direction.

I prefer not to take a course that I need to pay for.
 
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W

William_55401

#2
Re: Learning ISO 13485

Welcome! Reading and building a library of desk and on line resources is going to be your best bet. A book that I have found very helpful is Kim Trautman's book on the FDA and Worldwide QS Reqirements for Medical Devices. It covers FDA and 13485 in one book. It is on Amazon. No, I do not earn a commission. Good luck.
 

sagai

Quite Involved in Discussions
#3
Re: Learning ISO 13485

I do not think the essential knowledge can be gained without having someone sharing her/his experience in the industry.
Reading the standard without putting into proper context is more or less for me a waste of time.

I do not know your background, may be that would help us to suggest something sensible.
Cheers!
 
M

moocow

#4
Simplify

I am the QA/RA managers assistant... the training I got, went in one ear and out the other. I just want a better understaning of it all. Like I said I have no experience in with ISO. So im looking for outside help
 

Marcelo

Inactive Registered Visitor
#6
Read some books from quality gurus - Deming's two books, and Juran on quality by design and planning for quality is what I recommend.

The read ISO 9000 Quality Systems Handbook by David Hoyle.

After that, you will have a very good knowledge of quality systems in general. The ISO standards on quality systems are really nothing more than reflections of good practices from the field of quality management.

For quality systems in the medical device field, you may gain a lot of knowledge from the FDA Medical Device Quality Systems Manual and all the preambles to 21 QSR 820.
 
Last edited:

Gert Sorensen

Forum Moderator
Moderator
#7
Funny thing, that no one mentions the obvious place to start gaining knowledge about this subject, when on a limited budget: Here at Elsmar. It will give you so much more knowledge to start with than any book you can buy!! Once you have started getting a foundation here, then the books suggested will be beneficial, but the strength of the forum is that you can practically always find a discussion that matches your information-need. So, keep it up, ask questions and get involved :)
 
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