Research & Development
Intralink-Spine's Quality Management System passes ISO-13485 certification
9 October 2019 -

Intralink-Spine Inc (ILS) reported on Tuesday the receipt of the ISO 13485:2016 certification for its Quality Management System (QMS).

Following a review by MedCert GmbH, the ISO certification reflects ILS' commitment to the highest level of medical device quality controls and meeting customer and international regulatory expectations as it prepares for commercialization.

The certification process included an on-site audit of ILS's newly constructed GMP manufacturing facility in Lexington, KY. Its manufacturing facility for Réjuve production conveyed its commitment to product quality. It has the necessary infrastructure and controls to produce Réjuve in compliance with all quality requirements, states Bruce Choi, VP Quality & Operations.

ILS said it was formed to manufacture and exclusively sell the Réjuve medical device to treat Degenerative Disc Disease (DDD), low back pain and related spinal diseases including spondylolisthesis.

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