3D Systems和退伍军人卫生管理局(VHA)已签订合同,以使用在护理点生产的下一代医疗设备更好地为退伍军人服务。通过这项合作,3D系统将支持退伍军人卫生管理局,因为他们在医院内建立了符合FDA的制造设施,以生产加化性制造的医疗设备。结果,VA网络将简化其供应链和加速创新,以增强其患者的个性化护理 - 美国退伍军人。
The VA will collaborate with 3D Systems’ healthcare additive manufacturing team to design medical devices and take them through FDA clearance. 3D Systems’ application experts will initially manage the regulatory paperwork and development of a quality management system at VHA facilities, and over time will train the VHA teams to take ownership of the process. The training will also include how to run the quality management system, and how to complete product submissions for regulatory clearance. The solution will include the company’s ProX SLS 6100 3D printers and materials, as well as 3D Systems’ VSP-related workflows and software.
3D Systems Healthcare产品开发总监Ben Johnson说:“在医疗保健等高度监管的环境中,该技术只是解决方案的一小部分。”“对于客户成功而言,变得更加至关重要的是与具有在受监管环境中运作的知识和专业知识的公司的合作伙伴关系。Through this collaboration, 3D Systems will not only be installing 3D printers at the VHA sites, but we’ll also be helping them install a quality management system that includes the processes, documentation, and training required to be compliant as a medical device manufacturer.”
这项举措是3D系统与VHA之间的合作扩展,以解决COVID-19-19大流行的早期供应链问题。当时,VA需要PPE - 特别是面罩。随着停止间隙面膜的最终设计进入生产,接下来的VHA转向3D Systems团队,以帮助开发3D打印的鼻咽拭子,该拭子可以在生产级别的设备上印刷。
“What began during the pandemic in response to a critical need has expanded to change the way healthcare is delivered,” said Menno Ellis, executive vice president, healthcare solutions, 3D Systems. “This is a one-of-a-kind collaboration between an additive manufacturing solutions provider and one of the world’s largest integrated health care systems to accelerate innovation in the medical device production and deployment arena. 3D Systems’ team of experts is collaborating with the VHA team both in our facilities and on-site at the VHA to enable on-site production of medical devices, and help improve the quality of care they deliver to this very important patient population.”
3D Systems
www.3dsystems.com
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