Managing the quality of a medical device is of the utmost importance. Also for custom-made devices and 3D printed devices. In the medical devices industry, controlling the quality of CNC-milled or cast devices is commonplace, whereas quality management for 3D printed devices is still challenging. It involves a.o. design control, raw material control (powder management), machine validation (IQ, OQ, PQ), contamination control, controlling mechanical properties, post-processing,…
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See the blog post: Quality of 3D printed titanium cranial plates