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jackietorfinThe Long and Winding Road - Shortcuts to FDA Market Authorizationby Mark Swanson and Steve Gompertz, QRx Partners While most medical devices are required to follow the 510(k) and PMA pathways, the FDA...
jackietorfinLikely EU MDR Postponement: EU Finally Sees the Lightby Steve Gompertz, QRx Partners If you’re involved in the medical device industry, you’ve likely heard recently that the EU is...
jackietorfinQuality Management System Implementation is SO EASY....Why implementing a QMS is NOT as easy as we're told...