| 3D printing has made significant headway in healthcare and medical applications, with Dr. Scott Gottlieb, FDA Commissioner, recently issued a statement to the 3D printing healthcare industry, also reiterating The agency's commitment to a new era of 3D printed medical products.  Laura Gilmour, EOS Global Healthcare Business Development Manager FDA finalized its guidance on additive manufacturing technology that is significant to the industry as the medical industry is an early adopter of additive manufacturing equipment and as noted in the document, the FDA recognizes that between materials, machines and processes The importance of interaction to the quality part is already a core pillar of the EOS development process and the support of our customers. EOS's rigorous testing system provides manufacturers in the medical field with the ability to change process variables while maintaining FDA guidance, and regulators in the United States recognize the importance of materials, machines and processes interacting to provide patients with high quality medical equipment. Todd Pietila, Senior Business Development Manager, 3D Printing at Materialize Hospital Materialize has been closely following FDA recommendations and we appreciate the FDA's efforts to provide advice based on an in-depth study of additive manufacturing for medical applications, and we believe the FDA supports the development of 3D printing and the promises it makes to ensure safe and effective hospital use Implementation of 3D printing applications. 3DHEALS consultant Kate Clancy The finalization of the document provides a clearer route to regulating the wilderness, which is particularly important for start-ups who understand that FDA regulations may be novices, and it sets out the possible undetermined considerations. The FDA provides more specific guidance on how validation and use of standards in the manufacturing of medical devices should be made in order to facilitate regulatory approvals or approvals, which are of paramount importance in waiting for regulators to respond to current innovations. Kim Torluemke, Vice President, Healthcare Quality and Regulation, 3D Systems With more than 25 years of experience in the healthcare industry, 3D Systems is committed to maximizing customer expectations in products and services, and with a well-established quality management system and extensive regulatory experience, 3D Systems offers a vast array of 3D printed medical devices in the marketplace, And is committed to enhancing the treatment of children and adults through the use of 3D printing technology.We will continue to work with regulators to ensure compliance and to support the development of advanced precision medical regulations. Source: 天工 社 |
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