Tuesday, June 5; 9 AM – 10 AM
Speakers: Maureen Mooney, Senior Principal Specialist, Regulatory & Quality Solutions (R&Q)
Karen Rittle Leigh, International Regulatory Manager, 3M
Speaker introduction and moderation: Juli Denny, Vice President of Sales & Marketing, Regulatory & Quality Solutions (R&Q)
Wonder no more. Pulling from experience of successfully executing large-scale EU MDR implementations for multinational companies, this session will demonstrate what effective and efficient implementation of the EU MDR looks like. We will share lessons learned from every aspect of the implementations we’ve conducted, from gap assessments of regulatory files and the QMS to the transition to Technical Documentation and pilot submissions to the notified bodies. Additionally, we’ll discuss challenges experienced and solutions developed for addressing new requirements with clinical evidence, economic operators, post-market surveillance data , and much more.
Attendees will be presented with actionable tips and tricks gleaned from our first-hand experience and lessons learned, returning to their organizations with ideas and recommendations to impact the development of project plans, schedules, processes, templates, portfolio plans, budgets, and more.