Posts in category: Medical

What do certification bodies or notified bodies look at when validating additive manufacturing processes? In the MedTech sector, their focus will be on personnel qualification and, in particular, the process chain. In its new white paper, TÜV SÜD outlines the state-of-the-art manufacturing method and takes a closer look at the applicable standards. “We point out existing gaps and potential issues related to the additive manufacturing of medical devices, and outline feasible procedures”, said Simon Schlagintweit, Lead Auditor Additive Manufacturing at TÜV SÜD. The publication explains the individual steps in process chain qualification and validation and discusses the post-processing of products. The white paper’s target audience includes industry representatives, but also decision-makers in point-of-care diagnostics in areas such as research institutes and hospitals.