Our eSTAR interface is changing the game on FDA 510(k) submissions

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Our eSTAR interface is changing the game on FDA 510(k) submissions

Discover More

Our eSTAR interface is changing the game on FDA 510(k) submissions

Discover More

Our eSTAR interface is changing the game on FDA 510(k) submissions

Discover More

Expert Webinars

RIM Implementation

Oct 23, 2025

An AI-Powered RIMS Solution that Works: Lessons from Terumo's Rollout

Discover the proven 7-step playbook that helped Terumo Medical Corporation launch their AI-powered RIMS in under 90 days—and learn why 95% of AI implementations fail while theirs succeeded. Featuring insights from RAPS Convergence 2025.

RIM Implementation

Sep 27, 2023

Adopting a RIM Platform in MedTech: Myths vs. Reality

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

Generative Artificial Intelligence

Aug 9, 2023

MedTech Regulation vs. Innovation: Can They Live Happily Together?

Regulation vs. Innovation in the medical devices industry represent an essential and never-ending balancing act and dance that must play out. In this roundtable webinar, four longtime MedTech industry experts will dissect and discuss challenges manufacturers face as they work to comply with rules and regulations.

Essenvia & MedTech Summit

Jun 26, 2024

Digital Transformation in MedTech Reg Affairs: A "Must" or a "Nice to Have"?

MedTech transformation and how it connects to digital transformation is explored in this presentation from the 2024 MedTech Summit in Brussels. Viewers will gain insight into top digital priorities that medical device company executives and leaders are actively pursuing, the myriad challenges regulatory affairs professionals face in this space, and much more.

Essenvia & MedTech Intelligence

Jun 17, 2024

2024 State of US MedTech Regulation

This timely webinar dissects the recent US MedTech regulatory landscape for a number of topics, including medical device innovation and digital transformation, AI and machine learning, US FDA product submissions, and much more. Based on a sweeping 30-page Essenvia expert report, viewers will learn strategic insights, guidance, and best practices to navigate shifting regulatory expectations in 2024 and beyond.

Essenvia & MedTech Intelligence

Sep 26, 2023

Crossing the eStar Chasm

How to rapidly transition to FDA's mandatory eStar submission process.