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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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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Bridging the GAP Agile/Compliance

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.

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.

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Crossing the eSTAR Chasm: Transitioning to FDA’s Mandatory 510k eSTAR Submission Process by October 2023

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.

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.

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