Australia – TGA advises on 3D-printed device risks

Three dimensional (3-D) printing (an additive manufacturing process), is a process where computer-aided-design (CAD) software or a 3-D scanner is used to develop an object, which then informs a hardware manufacturing process where material is deposited in layers to form that specific three dimensional object. Additive manufacturing is being used more frequently to manufacture medical devices and their components. While there are often advantages to using 3-D printing for these kinds of products, there are also specific risks that arise that must be documented and reduced as much as possible by manufacturers in order to ensure their product is safe and fit for its intended purpose…