2024 State of the US MedTech Regulation: Innovation, Regulatory Transformation, and Artificial Intelligence

Essenvia unveils its 2024 State of US MedTech Regulation Industry Report that highlights shifts in innovation, AI & digital transformation in MedTech operations, and regulation in the United States medical device industry and provides MedTech executives and regulatory leaders with strategic insights, guidance, and best practices to navigate the shifting landscape in 2024 and beyond.

Essenvia unveils its 2024 State of US MedTech Regulation Industry Report that highlights shifts in innovation, AI & digital transformation in MedTech operations, and regulation in the United States medical device industry and provides MedTech executives and regulatory leaders with strategic insights, guidance, and best practices to navigate the shifting landscape in 2024 and beyond.

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Mastering Compliance: Essential Insights into PMS Documentation

Explore and understand the critical elements of PMS documentation and empower yourselves with effective strategies to navigate its complexities. In this webinar, we will delve into the significance of PMS documentation for medical devices, offering invaluable insights on ensuring compliance with regulatory requirements.

Explore and understand the critical elements of PMS documentation and empower yourselves with effective strategies to navigate its complexities. In this webinar, we will delve into the significance of PMS documentation for medical devices, offering invaluable insights on ensuring compliance with regulatory requirements.

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High Risk AI under the AI European Act: Must Know Strategies for Medical Device Companies to Achieve Regulatory Excellence

This session is designed to clarify high-risk AI applications within medical devices, helping your team to identify your regulatory responsibilities and plan your strategy effectively. 

This session is designed to clarify high-risk AI applications within medical devices, helping your team to identify your regulatory responsibilities and plan your strategy effectively. 

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Japan Medical Device Registration & Reimbursement

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.

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.

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MTI Regulatory Intelligence and Networking Summit

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.

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.

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Post-EU MDR Compliance: Key Insights and Activities to Maintain Compliance after Device Certification

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 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.

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Real-World Evidence: Not Just for PMCF

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.

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.

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Optimizing CER and PMS Document Writing with Technology and AI

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.

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.

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EU MDR & IVDR Lessons for Regulatory Strategy

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.

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.

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