WOBURN, Mass.--(BUSINESS WIRE)--Claros Diagnostics, a developer of novel point-of-care immunoassay systems, reported the receipt of corporate ISO 13485 and CMDCAS certificates of registration issued by the National Standards Authority of Ireland (NSAI). ISO 13485 is an internationally recognized standard which defines the requirements for design, development, production, and distribution of medical devices. It validates that Claros has processes in place to control the development and production of safe and effective medical devices. Achieving ISO 13485:2003 certification under CMDCAS further demonstrates corporate compliance with the Canadian QMS regulatory requirements for medical device licensing.
