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Empirical Bioscience, a privately-held developer and manufacturer of enzymes, polymerases, and reagents for Molecular Biology applications, announced that it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems, this is an upgrade from their ISO 13485:2003 certificate. 

This certification more closely aligns with FDA regulatory guidelines and is an international standard that outlines the requirements for a quality management system specific to the medical device industry.

ISO 13485:2016 is an internationally recognized quality standard intended to provide a quality framework focused on the consistent design, development, servicing and sale of medical devices that are safe and effective for their intended purposes.  To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements.

“This certification is further evidence of our commitment to quality and ensures every Empirical Bioscience customer – from research institutions to an OEM customer who purchases custom reagents and complete test kits – receives products and services of the highest standards for product performance, quality, consistency, and reliability,” said Beth Lowe, Quality Systems Manager of Empirical Bioscience. “With a focus on maintaining a world-class quality management system and as one of the few privately-owned companies in our market space, Empirical Bioscience is an organization that customers can confidently rely on to meet and exceed expectations,” said Des O’Farrell, President of Empirical Bioscience.

Empirical Bioscience produces high-grade PCR reagents and enzymes in its ISO 13485 certified facility in Grand Rapids, MI, USA and is a Registered Small Business Company.