Sessions
Navigating the Transition: Moving from FDA QMSR to ISO 13485 for Medical Device Quality Management
3:00 PM - 5:00 PM Mon
Optimizing Medical Device Life Cycle Management: Navigating Regulatory Pitfalls and Enhancing Compliance Across Global Markets
9:20 AM - 9:55 AM Wed
Joy Greidanus, Director – Medical Device SME
• Joy has more than 30 years of experience working in the medical device manufacturing industry as a Regulatory Affairs Professional.
• She has strong experience and expertise that includes US submissions, collaborative interaction with FDA, strategies for medical device, pre-market notifications, IDE applications, clinical trial notifications, research ethics committee submissions, developing / maintaining technical files and design dossiers, international marketing authorizations, risk management, design control, and regulatory compliance.
• Joy has worked with Cardinal Health, Becton Dickinson, Baxter, Teleflex Medical, Hospira, CareFusion, Fresenius Kabi USA, and TIDI Products LLC before Celegence.