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for FDA Accepted Predetermined Change Control Plans!Written by Mark Swanson, Partner On April 3rd, the FDA issued the draft guidance titled, “Marketing Submission Recommendations for a...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...
jackietorfinDec 16, 20223 minLikely 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...
