Advancing Patient Care with Certified Additive Manufacturing in Healthcare

Additive manufacturing has achieved rapid and widespread adoption in the healthcare sector, revolutionizing the production of patient-specific medical devices such as implants, prosthetics, dental devices, and intricate surgical instruments. The technology’s ability to deliver unparalleled customization has led to improved patient outcomes and significant advancements in medical treatments. Ensuring exceptional quality is paramount due to the direct impact on patient safety. Comprehensive testing for biocompatibility, sterility, and mechanical performance is essential to the meet stringent regulatory requirements of the Medical Device Regulation (MDR) in Europe or the FDA in the United States of America. Additive manufacturing standards such as ISO/ASTM 52920 provide process-agnostic requirements for establishing quality-assured AM processes, ensuring consistent quality across various process categories. Qualified AM assist healthcare manufacturers in navigating these complex standards and regulations, ensuring their AM products meet the highest quality criteria and comply with international requirements, thereby supporting the sector’s continued growth and adoption of AM technologies.