jackietorfinApr 212 minGet Ready for FDA Accepted Predetermined Change Control Plans!Written by Mark Swanson, Partner On April 3rd, the FDA issued the draft guidance titled, “Marketing Submission Recommendations for a...
jackietorfinMar 234 minAuditing, the Often-Thankless Taskby Steve Gompertz, QRx Partners Performing audits is great way to increase your understanding of quality management system requirements...
jackietorfinJan 252 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...
jackietorfinAug 4, 20222 minHow the FDA Warning Letter to Young Living Essential Oils should influence Influencer MarketingWritten by: Jackie Torfin, Partner A warning letter published on July 19th by the FDA to Young Living Essential Oils names not only the...
Jackie TorfinJun 15, 20223 minProcess Approach: The Missing Link to an Effective QMSWritten By: Steve Gompertz, Partner It’s pretty common for Quality Manuals to depict the Quality Management System (QMS) structure as a...
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...