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Quark Biosciences, Inc. achieves ISO 13485:2016 Certification

Quark Biosciences, Inc. has received certification from the SGS on July 17, 2020, that our quality system meets the ISO 13485 Standard for Medical Device and Diagnostic Product Development and Manufacturing.

Audit scope: design, develop, manufacture, and sell nucleic acid analysis systems – analysis and chips – for in vitro diagnosis.

QuarkBio will take this certification as a starting point for our ongoing efforts on improving the quality management system to meet regulatory requirements and customer needs.

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