IDE Submission Best Practice, and Pitfalls to Avoid - from Both Regulatory & Clinical Perspectives Date: Wednesday, May 15, 2024 Time: 5:30pm – 7:30pm PT Audience: Regulatory and clinical affairs professionals in medical device industry Location: OCRA-DG, 2400 Barranca Parkway, Irvine, CA 92606 This panel...
A Walk Through FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance Date: Wednesday, May 22, 2024 Time: 12pm – 1pm PT Audience: Medical device quality assurance, regulatory affairs, and R&D leaders and practitioners.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...
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See https://ocra-dg.org/2024-annual-conference/ for event details!
More information to come - dates and topics subject to change.
topics to be announced Check back for more info!
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