Japan is the 3rd largest medical device market in the world. However, being successful in Japan requires investigating a number of factors before registration. In this webinar, you’ll learn best strategies to register your device in Japan and get device reimbursement.
Join us for a discussion on Essential Strategies to navigate the regulatory landscape and ensure you get your device to market on time and with the right tools.
This webinar goes beyond theory, delving into real-world case studies that spotlight successful PMCF implementations, providing actionable insights and lessons. Don’t miss this opportunity to refine your approach to PMCF and ensure compliance while optimizing product performance in the market.
The MTI Regulatory Intelligence & Networking Summit is an intimate and interactive forum designed to help regulatory leaders and their organizations recognize and understand key trends, challenges, and solutions impacting the strategy, execution, and monitoring of MedTech regulatory process and compliance.
Join Hilde Viroux, Consulting Director at PA Consulting, and Adam Price, Director or Product, at Rimsys for a discussion about the elements of successful post-EU MDR compliance, including key challenges, post certification requirements and considerations when assessing your organization’s preparedness.
Join us for a panel discussion on use of real-world evidence in regulatory assessments. Get an up-to-date perspective on the key concerns, benefits, challenges and approaches that manufacturers must consider when using real-world evidence to meet their regulatory submission requirements.
This webinar delves into common non-conformities encountered during clinical evaluations and explore how technology can play a pivotal role in resolving these challenges. We will also discuss practical process adjustments made to prevent the recurrence of these non-conformities in subsequent reviews.
The new EU (and forthcoming UK) regulations have underscored the significant relationship between regulatory and revenue. This webinar covers some of the key strategic capabilities including regulatory data management, process automation, and tighter alignment with in-country sponsors and Notified Bodies of high-performing regulatory teams, and outlines steps organizations can take to foster stronger regulatory – revenue alignment.
Bridging the gap between agile and compliance is a hard task. Join this webinar to gain a better understanding on how your R&D, QA and Compliance teams can work better together.
This webinar will educate and prepare medical device manufacturers, regulatory affairs leaders, and regulatory consultants to effectively transition their processes, resources, and operations to seamlessly adopt the eSTAR as the new submission standard. This session will share watchouts, best practices, and tips and tricks to adapt to eSTAR.