Formlabs manufactures our Biomed and Medical Device Resins at our FDA-registered facility in Ohio. These materials are designed and manufactured within our robust Quality Management System that is ISO 13485 and EU MDR certified. A dedicated team of operators and quality assurance professionals makes the resins inside a certified ISO Class 8 clean room. All of our Medical Device Resins are appropriately registered with the FDA and CE marked according to the EU MDR.