Quality Management System

BioLegend, headquartered in San Diego, CA, has passed the Medical Device Single Audit Program (MDSAP) certification audit in October, 2019. BioLegend’s Quality Management System was audited by notified body; TÜV SÜD, an accredited certification body for ISO 13485:2016 and MDSAP, and was found to conform to the requirements for MDSAP, as well as ISO 13485:2016. The certification is part of BioLegend’s commitment to quality, continuous improvement, and enabling legendary discovery from research to cure, allowing the company to move forward with diagnostic products and GMP grade proteins globally.

View ISO 13485:2016 Certificate

View MDSAP Certificate