Qualifying for ISO-13485 certification is a comprehensive process where a notified body reviews the quality control protocols a company has in place. The certification is an entirely voluntary process that companies use to denote the high standards of their products.
Intralink vice president of quality and operations Bruce Choi said the MedCert GmbH, a notified review body, audited Intralink’s GMP manufacturing facility in Lexington, Ky.
Mr. Choi elaborated on the process, saying, “This certification demonstrates that Intralink-Spine has the necessary infrastructure and controls to produce Réjuve in compliance with all quality requirements.”
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