The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
Extractable/leachable chemistry testing can save, time, money, and animal life for certain classes of devices. Over the past decade, regulatory bodies have shifted their evaluation of biocompatibility from a strict linear approach to a less linear approach that includes in...
The use of three-dimensional (3D) printing techniques to address challenging fabrication problems has become mainstream over the past decade. While this rich resource has extended fabrication of personalized medical devices to the limit of our imagination, the myriad materials and...
Posted in Printing Services by MDDI Staff on May 24, 2016 A new leapfrog guidance from FDA gives a glimpse into the agency’s thinking on 3D printed medical devices. On May 10, 2016, FDA released a leapfrog guidance document on the...
The previous three posts addressed biocompatibility concerns of 3D printed devices considering additives to the raw materials, the material curing process, and post-printing finishing processes. Both thermoplastics and photopolymers contain additives (oligomers, plasticizers, preservatives, etc.) that are freshly redistributed through...
In the previous two posts, the biocompatibility of 3D printed devices was discussed with consideration for the possible compounds added to the raw materials for workability and the polymer precursors and byproducts associated with photopolymerized structures. In both of these...
