I couldn't seem to find the answer elsewhere. We are a U.S manufacturer producing a Class II device with 510(k) clearance and looking to get the device CE marked. Is it possible for us to fall under another company's ISO 13485: 2016 considering that we do not have one of our own? What are some of the cons to us and the other business adding us to their ISO cert? I'm curious if this is a feasible option for both sides. Initially, the customer with ISO expressed interest in CE marking a convenience kit that included our class II device. But we are hoping to CE mark the device so it can be sold to EU on our own and the customer can use it in their own kit as well.