Episode#127 | Lean Compliance For Medical 3D Printing With Erik Boelen

We talk with Erik Boelen, founder of Qase3D, about how medical 3D printing went from a regulatory free-for-all to a world where hospital print labs function as medical device manufacturers. We break down MDR, CE marking, ISO 13485, and how to stay compliant with a lean system engineers will actually use. • The early “no rules” era and why proof of quality becomes unavoidable • How MDR and CE marking work for standard medical devices • Why custom-made devices can be CE-exempt...