We are a contract manufacturer of die cut components, such as adhesives, gaskets, films, etc., that are used by our customers as components in their finished devices. We don't design or make any finished devices. We are transitioning from 13485:2003 to 2016, and our audit is in October.
Currently, our DMR includes things like drawings, quotations (from us to our customer, and our vendors to us, etc.), change orders, etc., but they're all related to the little component we're making, not an actual medical device.
We have some customers for whom we make several different parts, and they also make several finished devices. We have no idea how many, or which of our components goes into which of their devices, or how their devices are used.
Do we simply need to add a checklist (demonstrating conformity to this requirement), showing that we have at least just the things that apply? For instance, we would have a design record, but not necessarily instructions for use, since our customer designed this component, and knows how to use it in the building of their device.
Currently, our DMR includes things like drawings, quotations (from us to our customer, and our vendors to us, etc.), change orders, etc., but they're all related to the little component we're making, not an actual medical device.
We have some customers for whom we make several different parts, and they also make several finished devices. We have no idea how many, or which of our components goes into which of their devices, or how their devices are used.
Do we simply need to add a checklist (demonstrating conformity to this requirement), showing that we have at least just the things that apply? For instance, we would have a design record, but not necessarily instructions for use, since our customer designed this component, and knows how to use it in the building of their device.