Today Intralink-Spine, Inc. announced that it has received ISO 13485:2016 certification for its Quality Management System (QMS) following review by its notified body, MedCert GmbH. ISO 13485:2016 is an internationally recognized quality standard specific to the medical device industry and signifies Intralink-Spine’s commitment to the highest level of medical device quality controls and meeting customer and international regulatory expectations.
“The certification process included an on-site audit of ILS’s newly constructed GMP manufacturing facility in Lexington, KY. I am proud that our manufacturing facility for Réjuve™ production conveyed the company’s commitment to product quality. This certification demonstrates that Intralink-Spine has the necessary infrastructure and controls to produce Réjuve in compliance with all quality requirements,” states Bruce Choi, VP Quality & Operations.
“Réjuve is an intervertebral disc crosslinking device intended to treat disc degeneration and associated chronic low back pain (CLBP). Réjuve mechanically stabilizes the spinal joint and strengthens the disc tissue to counteract the effects of degenerative disc disease, thereby potentially reducing low back pain. The unique ability of Réjuve to address the core issues contributing to CLBP and progressive and debilitating tissue degradation is even more important in view of the current opioid addiction crisis, where prescription of opioids following back surgery or as part of a treatment regimen for CLBP has played a role in this epidemic,” states Tom Hedman, Ph.D., Founder and CSO of Intralink-Spine, Inc.
“The ISO certification is a significant milestone for ILS and demonstrates the company’s commitment to meet quality standards as we prepare for commercialization,” says Lyle Hawkins, CEO, of Intralink-Spine, Inc.
According to Hawkins, “When you consider just a few of our milestone achievements such as ISO-13485 certification , twenty-seven issued patents, thirty-two peer reviewed papers, two long-term large animal studies, successful completion of ISO 10993 biocompatibility testing, two-plus years of patient safety data, and additional patient data coming from Australia, you’ll understand why we’re excited about the months ahead as we pursue our commercialization objectives.”