Electronics Forum | Fri Apr 12 11:37:59 EDT 2019 | slthomas
Are you currently ISO 13485 certified, or are you just trying to meet compliance standards for a certified customer?
Electronics Forum | Fri Apr 12 14:17:40 EDT 2019 | tey422
We are ISO 13485 Certified. The previous PE who handles such technician things is no longer working with us. I am not sure where to start at, and what exactly needs to be done. Current, my main question is there some sort of a list what would be the
Electronics Forum | Mon Apr 15 12:45:49 EDT 2019 | slthomas
The reason I asked is that in every AS9100 or ISO13485 environment where I've been employed our equipment qualifications have included a PQ in order to provide evidence that the machine can (and did) produce product that meets or exceeds the pass/fai
Electronics Forum | Tue Feb 09 16:04:06 EST 2010 | frankalbiter
Hi there, From the ISO 13485: 2003 std. standpoint, there is a special requirement which states: "The following requirements shall apply. d) If appropriate, special arrangements shall be established and documented for the control of contaminated or
Electronics Forum | Tue Jul 23 18:19:30 EDT 2019 | slthomas
It depends on what you mean by "going from....to....". If I just decided that I wanted to try a Type 4 paste on something that I'd been having problems printing, I'd probably just grab one (edited to add that we have a couple of re
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