GRAND RAPIDS BUSINESS JOURNAL: announced it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems

Empirical Bioscience announced it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems, 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.