A Walk Through FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance Date: Wednesday, May 22, 2024 Time: 12pm – 1pm PT Audience: Medical device quality assurance, regulatory affairs, and R&D leaders and practitioners. Platform: Zoom In April 2023 FDA published its Marketing Submission Recommendations for...

Struggling with determining the regulatory pathways for your device in China? Which pathway needs clinical evidence? Is clinical trial needed to support your device registration in China? This webinar provides an overview of the critical elements of China's registration and clinical pathways, focusing on the...