New Medical Device QA Manager Needs Help

T

theGrod

#1
Hello -- I have recently moved from automotive to medical device. We are in the process of business growth and will be going through our ISO-13485 Registration audit in a couple of months. We are a small mostly distribution and sales center for a large Swiss company. We have one product that we manufacture here in house and it is a very basice device. We are FDA Class 1; 501(k) exempt. We don't do any design or development but we do make modifications and sometimes and upgrade to the product we manufacture inhouse. In working on development of our QMS a lot of things do not fit "neatly" into the requirements of the standard. We are very low volume as well which makes the process control and traceability requirements fit even less neatly into the standard. So is there others out there that have a similar experience and can help make some sense out of this. I have been in ISO auditing for almost 12 years and this is a totally new animal for me, and I want to make sure I am covered.
 
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DannyK

Trusted Information Resource
#2
Re: New QA Manager Needs Help

As a medical device consultant and also lead assessor for a registrar, I have encountered many "non-standard" situations.
I would encourage you to post your specific questions and someone will provide you with the answers.
You are more than welcome to send me a private message and I will be glad to answer your questions.

Danny
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: New QA Manager Needs Help

Hello -- I have recently moved from automotive to medical device. We are in the process of business growth and will be going through our ISO-13485 Registration audit in a couple of months. We are a small mostly distribution and sales center for a large Swiss company. We have one product that we manufacture here in house and it is a very basice device. We are FDA Class 1; 501(k) exempt. We don't do any design or development but we do make modifications and sometimes and upgrade to the product we manufacture inhouse. In working on development of our QMS a lot of things do not fit "neatly" into the requirements of the standard. We are very low volume as well which makes the process control and traceability requirements fit even less neatly into the standard. So is there others out there that have a similar experience and can help make some sense out of this. I have been in ISO auditing for almost 12 years and this is a totally new animal for me, and I want to make sure I am covered.
Hello and welcome to the field!...

One comment - If you actually do make "modifications" or "upgrades' to an existing product then you probably ARE involved in design. Maybe the process is not well formalized / controlled / perceived as such, but I assume that the modifications are not random or arbitrary, right?... Hence some sort of design process occurs, and so I would encourage you to look at making it part of your quality system (though most class 1 devices are exempt from formal design controls, 21 CFR part 820.30).

Good luck and feel free to ask anything.

Cheers,
Ronen.
 
T

theGrod

#5
Re: New QA Manager Needs Help

We do have a "modified" form of Design Change Control set up as part of our system. It seems sufficient for our organization and our organization's operation.
 
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