| Salutaris Medical Devices, Inc. (SalutarisMD®) announced it has received ISO 13485:2003 certification, an internationally recognized standard for medical device quality systems, marking completion of a critical step in efforts towards commercialization of the SalutarisMD technology for the treatment of wet age-related macular degeneration (wet AMD).
The ISO 13485:2003 certification covers the design, development, production, and distribution of the company’s medical device products. The certificate demonstrates that SalutarisMD has successfully implemented a rigorous quality management system that conforms to the worldwide standard for medical device and diagnostic manufacturing. ISO 13485 is a quality management system standard accepted as the basis to begin the CE marking of medical devices under European Medical Device Directives.
“Obtaining this certification is an important milestone in our commercialization and the culmination of a tremendous team effort. This achievement demonstrates SalutarisMD’s continued commitment to the highest level of quality management and design controls to ensure delivery of safe and effective devices,” said Dr. Laurence Marsteller, CEO of SalutarisMD.
Caution: Investigational Device Use Only
SalutarisMD® (Salutaris Medical Devices, Inc. and Salutaris Medical Devices, Ltd.) is a pre-revenue medical device company founded to develop an investigational ophthalmic treatment for wet age-related macular degeneration (wet AMD). SalutarisMD is developing a minimally invasive procedure that can be performed in an outpatient setting in approximately 15 minutes. The patented and patent pending technology delivers a single-use brachytherapy procedure. SalutarisMD’s technology is being engineered to deliver improved outcomes for wet AMD. For more information visit www.SalutarisMD.com or www.SalutarisMD.co.uk.