Regulators the world over are raising the bar for medical device compliance, and no more so than in Clinical Evidence requirements. Every device and IVD no matter its risk class must have formal clinical evidence showing real-world safety and performance. New guidances in Europe, Australia and China specifically require direct clinical trials as a default position for high-risk devices. More and more US FDA 510(k) submissions must include direct clinical testing data.
At the end of the workshop you will have a clear understanding of the key global requirements and how to construct Clinical Evidence Dossiers to support global regulatory filings and ongoing compliance.
ARCS Training Room, Crows Nest, NSW
Upon completion of this workshop, attendees will receive 7 CPD points. Attendees who successfully complete the post-workshop exam will receive 2 CPD points.