Hi, we are in process of implementation of ISO13485. We don't do final medical devices/product, but only components for medical devices, therefore we are not technical file owner and design owner. So I am wondering how we should implement Risk Management and related risk assesment, since we don't have overview on final product life-cycle. Beside PFMEA, are DFMEA and UFMEA applicable for us as well? Thank you in advance?