I'm in the same boat. I recently changed employers, and am working with a component supplier who is going after 13485 certification. My background is 95% automotive for the last 20+ years, so everything specific to 13485/medical is a bit new to me. Add to that, that we're not really a medical device manufacturer, and it's been very difficult, yet enlightening, to research the best way to develop my QMS without boxing myself into any ridiculous requirements that would add unnecessary costs to our process, with little or no value added. I'm working on an advisory notice procedure now, and considering that we only manufacture components that are designed by our customers, with materials specified by our customers, and only delivered to our customers for them to assemble into their devices, it seems the advisory notice would never apply, yet the standard requires that I develop a procedure, so here I go. WOOT!!