For a quality manager in the medtech sector, choosing a 3D printing supplier isn't simply a technical assessment, but a decision linked to risk management. Every component produced can enter the medical device's technical file. Every non-conformity can generate a CAPA. Every MDR or FDA audit, sooner or later, can extend to the supply chain as well. The operational question, therefore, isn't: "Can you print in PA12?", but rather: " Are you able to demonstrate that the component received today will be equivalent to the one I'll receive in six months' time , and can you provide me with the documentation needed to support this evidence before my Notified Body?" This article explains how Weerg guarantees traceability, repeatability and documentation in the 3D printing process for medical applications, from the ISO 9001 quality system through to the documentation available for each production batch.