3rd Annual European Medical Device and Diagnostic Quality Management Meeting

With regulations such as MDR, IVDR, MDSAP and ISO 13485 in place, Medtech manufacturers are increasingly looking towards efficiency by partnering with raw material and component part suppliers who are reliable, compliant and cost effective. It is crucial for supplier quality management professionals to select right suppliers, manage them by establishing effective communication in the early stages of product development and qualify each suppliers based on risk level and supplier type, including traditional component suppliers, software suppliers, and chemical suppliers, as each suppliers require unique and differentiated qualification standards. With an increased focus on supplier controls in the updated regulations and a greater focus on risk management in the updated ISO 13485, manufacturers must review and update their supplier quality management (SQM) process by performing timely inspections and audits, as well as understanding the capabilities and needs of the supplier counterpart to avoid non-conformance.