jackietorfinJan 25, 20232 minThe 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...
jackietorfinMay 2, 20222 minRiding the wave of the new Quality Management System RegulationWritten By: Mark Swanson, Partner, CEO Having just returned from the MD&M West Conference in Anaheim, CA, it was interesting to hear what...
