FDA Recommendations for Device Testing Considerations in Additive Manufacturing
The healthcare industry, particularly in the medical device arena, is one of the strongest industry sectors in Fremont with a large number of device and equipment companies clustered in the city. As we know, industry trends are always changing, and healthcare is no exception. New devices, medications, and regulations are constantly shaking up the industry, changing the landscape for patients, physicians and health systems. Take additive manufacturing, for example, which is now becoming more widely adopted in the medical industry and leading to the development of new devices, implants and instrumentation to produce better clinical outcomes. Advanced manufacturing is changing the face of medical manufacturing by utilizing new materials and methodologies.
The Food & Drug Administration (FDA) is working to develop a comprehensive regulatory pathway that ensures the safety of 3D printed devices and implants. One of Fremont’s newest biomedical manufacturers, PrinterPrezz, is revolutionizing medical implant 3D printing by blending medical innovation with advanced design/manufacturing resources. They recently published a white paper on their website, focusing on FDA recommendations for manufacturers when testing devices or implants developed with additive manufacturing.
You can read more in PrinterPrezz’s white paper here: FDA Recommendations for Device Testing Considerations in Additive Manufacturing.