The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery

A comprehensive guide to calculating benefit-risk profiles under the EU MDR, focusing on practical strategies and tools to ensure regulatory compliance. Key topics include differentiating between qualitative benefit-risk profiles and quantified benefit-risk ratios, understanding when each is appropriate, and avoiding pitfalls that lead to non-conformances

A comprehensive guide to calculating benefit-risk profiles under the EU MDR, focusing on practical strategies and tools to ensure regulatory compliance. Key topics include differentiating between qualitative benefit-risk profiles and quantified benefit-risk ratios, understanding when each is appropriate, and avoiding pitfalls that lead to non-conformances

Continue reading →

Adopting a RIM Platform in MedTech: Myths vs. Reality

Implementing a Regulatory Information Management (RIM) platform can significantly enhance regulatory processes. However, several misconceptions often prevent medical device companies from adopting these platforms. In this webinar, we’ll debunk the most common myths and demonstrate how RIM platforms can quickly generate ROI.

Implementing a Regulatory Information Management (RIM) platform can significantly enhance regulatory processes. However, several misconceptions often prevent medical device companies from adopting these platforms. In this webinar, we’ll debunk the most common myths and demonstrate how RIM platforms can quickly generate ROI.

Continue reading →

Decoding global regulatory pathways: How to classify your Medical Device

Understand how different regions categorize medical devices. Ensure compliance and remain empowered with the knowledge to navigate international regulatory landscapes confidently. Whether you’re targeting the US market with its FDA requirements or aiming for EU approval under the rigorous MDR, we’ll break down the complexities and provide clear, actionable insights.

Understand how different regions categorize medical devices. Ensure compliance and remain empowered with the knowledge to navigate international regulatory landscapes confidently. Whether you’re targeting the US market with its FDA requirements or aiming for EU approval under the rigorous MDR, we’ll break down the complexities and provide clear, actionable insights.

Continue reading →

Managing global regulatory strategy and compliance: assessing status, gaps, and needs.

In this webinar, our industry panel of notified bodies, regulatory management & maintenance experts, and medical writers share details of this recent research, explore changing regulatory landscapes, identify the most critical gaps, and offer insights on knowledge, technology and resources to help improve regulatory intelligence and mitigate compliance deficits.

In this webinar, our industry panel of notified bodies, regulatory management & maintenance experts, and medical writers share details of this recent research, explore changing regulatory landscapes, identify the most critical gaps, and offer insights on knowledge, technology and resources to help improve regulatory intelligence and mitigate compliance deficits.

Continue reading →

Now that the EU MDR deadline is passed, how do you sell your device abroad?

As the EU Medical Device Regulation (MDR) deadline has passed, medical device manufacturers must explore alternative avenues to sell their devices abroad. Leveraging schemes such as MDSAP, Swissmedic, and UKCA in conjunction with ISO 13485, can facilitate market access in various regions.
This presentation describes options available to manufacturers who wish to access markets other than the EU.

As the EU Medical Device Regulation (MDR) deadline has passed, medical device manufacturers must explore alternative avenues to sell their devices abroad. Leveraging schemes such as MDSAP, Swissmedic, and UKCA in conjunction with ISO 13485, can facilitate market access in various regions.
This presentation describes options available to manufacturers who wish to access markets other than the EU.

Continue reading →

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.

Continue reading →

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.

Continue reading →

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. 

Continue reading →

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.

Continue reading →