Contact Us
"*" indicates required fields
Post-Market Clinical Follow-up (PMCF) has become one of the most closely scrutinized requirements under EU MDR. While manufacturers understand the importance of PMCF in demonstrating continued safety and performance, determining the right approach remains a significant challenge.
Organizations must decide how to generate meaningful post-market clinical evidence, select appropriate data collection methods, respond to evolving Notified Body expectations, and manage PMCF activities efficiently across their device portfolios.
This webinar brings together experienced industry leaders and medical device manufacturers to discuss real-world PMCF challenges and practical approaches to addressing them.
Online Webinar
March 12, 2025 | 10:00 AM ET
During this webinar, our panel discusses practical insights and real-world approaches, including:
Medical & Clinical Strategy Advisor
Julie Jakubowski is an Internal Medicine physician-executive with extensive experience in Medical Affairs and Clinical Development across pharmaceuticals, medical devices, and diagnostics. She spent over 13 years at Baxter International, where she led medical strategy across a $1B portfolio, supporting evidence generation, regulatory strategy, and product lifecycle management. Julie has also served as Assistant Professor of Medicine at Northwestern Memorial Hospital and has published in areas including metabolic disease, nutrition, and digital medicine.
Director, Regulatory Affairs, Acumed
Aram Tran is a regulatory affairs leader with 14 years of experience in orthopedic medical devices, spanning manufacturing, R&D, product management, and quality assurance. He currently leads Regulatory Affairs at Acumed, driving regulatory excellence and continuous improvement across functions including post-market surveillance, clinical affairs, sustaining, and new product introduction. His cross-functional expertise enables alignment between development, compliance, and business strategy.
Vice President of Global Regulatory Affairs and Quality, Argon Medical Devices
Scott Bishop leads global regulatory strategy and quality oversight at Argon Medical Devices. He brings extensive experience in EU MDR transitions, including technical documentation alignment, notified body engagement, post-market surveillance integration, and quality system readiness. Known for his risk-based approach, he aligns regulatory and quality strategy with business goals while maintaining compliance across global markets.
Priya Ray Chaudhuri
Priya Ray Chaudhuri is a life sciences professional with over 11 years of experience specializing in regulatory medical writing and clinical evaluation for medical devices. She has strong expertise in EU MDR documentation, including CEPs, CERs, and PMS/PMCF activities. At Celegence, she leads a team supporting clinical evaluation strategy, evidence generation, and responses to Notified Body reviews.
Share
