FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance Date: Wednesday, May 22, 2024 Time: 12pm – 1pm PT Audience: Medical device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...
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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Stay ahead of the curve with our expert-led webinar designed to empower you with the latest insights, updates, and best practices! Unravel the latest updates and changes in the FDA CDRH's 510(k) Program, ensuring you're up to speed with the most current regulations The speakers...
See https://ocra-dg.org/2024-annual-conference/ for event details!
Early Registration until 31 May 2024 at 11:59 pm EST. Early Registration rate is $2,785 for non-RAPS Members and $2,205 for RAPS Members. OCRA Members receive 10% off RAPS Convergence registration rate! Contact Membership@ocra-dg.org to obtain the special promo code!
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