A Walk Through FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance Date: Wednesday, May 22, 2024 Time: 12pm – 1pm PT Audience: Medical device quality assurance, regulatory affairs, and R&D leaders and practitioners.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...
IDE Submission Best Practice, and Pitfalls to Avoid - from Both Regulatory & Clinical Perspectives Date: Thursday, May 30, 2024 (New Date!) Time: 5:30pm – 7:30pm PT Audience: Regulatory and clinical affairs professionals in medical device industry Location: Alcon Laboratories, 20511 Lake Forest Dr, Lake...
China Medical Device Registration Clinical Pathways Latest Updates Date: Wednesday, June 6, 2024 Time: 8am – 9pm PT Audience: Regulatory and clinical professionals in medical device industry Platform: Zoom Struggling with determining the regulatory pathways for your device in China? Which pathway needs clinical evidence?...
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See https://ocra-dg.org/2024-annual-conference/ for event details!
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