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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.