CDRH warned that more than 100 device manufacturers and hundreds of devices face potential shortages following an EPA order to stop medical equipment sterilizer Sterigenics’ Willbrook, Illinois facility from sterilizing products with eth... Read More
The European Medicines Agency issued final guidance on new rules for certain in vitro diagnostics and medical devices. Read More
The FDA hit four facilities for various failures including inadequate validations, CAPAs, written procedures and supplier evaluations. Read More
Australia’s Therapeutic Goods Administration reached the end of its three-year transition period to the 2016 version of ISO 13485 and devicemakers using the updated standard to show Quality Management System (QMS) conformity are now expe... Read More
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