GENOMEWEB: Empirical Bioscience Receives ISO 13485:2016 Certification for Medical Device and Quality Management Systems

Empirical Bioscience said this week that it has received ISO 13485:2016 certification for Medical Device and Quality Management Systems, which is an upgrade from its previous ISO 13485:2003 certificate. This new certification more closely aligns with US Food and Drug Administration regulatory guidelines and is an international standard that outlines the requirements for a quality management system specific to the medical device industry, the firm said. 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 receive such a certification, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements.

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