Mastering QMS Audit Readiness: Strategies for Preparation, Conduct, and Mitigation Mastering QMS Audit Readiness: Strategies for Preparation, Conduct, and Mitigation Webinar Join us for an insightful webinar where we'll delve into comprehensive strategies and tactics to help ensure your organization is prepared for your next...
FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance Date: Wednesday, May 22, 2024 Time: 12pm – 1pm PT Audience: Medical device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...
China Medical Device Registration Clinical Pathways Latest Updates Date: Wednesday, June 6, 2024 Time: 8am – 9am 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?...
What's New in FDA 510(k) & eSTAR Best Practice Date: Wednesday, June 26, 2024 Time: 12 noon – 1pm PT Audience: Medical device regulatory affairs professionals who are involved in the 510(k) submission process. Platform: Zoom The panel will provide an overview of the recent...
Social Summer Date: Friday, July 12, 2024 Time: 4 – 8pm PT Location: Bosscat Kitchen & Libations 18169 Von Karman Ave, Irvine, CA 92612 Free for Member $10 for Nonmember Register Now!
Navigating EU MDR Compliance for CE Marking Date: Thursday, September 12 Time: 12pm-1:15pm PT Audience: This webinar is recommended for professionals with some familiarity with EU MDR or the previous Medical Device Directive (MDD). Platform: Zoom This webinar aims to provide an overall understanding of...
