March 7, 2024

eSTAR 5.0: Are You Ready?

Version 5.0 of the FDA’s dynamic PDF known as eSTAR became effective February 4, 2024, bringing with it significant changes to cybersecurity, biocompatibility, clinical data, and more.

Register for this free, in-depth webinar where Michelle Lott from leanRAQA will guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for anyone planning a 510(k), De Novo, or PMA submission.

Spoiler alert: one of the biggest threats of eSTAR 5.0 is to your mental health! Protect your sanity and put yourself in a position to succeed by joining this must-attend session.

Specifically, this webinar will cover:
  • Review of the eSTAR platform: What you need to know to use eSTAR effectively –the good, the bad, and the ugly.
  • Understanding eSTAR 5.0: Learn about the new features, including premarket approval content and updated cybersecurity documentation.
  • Regulatory Compliance: Understand the simplified EMC questions, revised sterility section, and new biocompatibility testing options.
  • Practical Insights: Gain hands-on knowledge for completing a thorough 510(k) or PMA application using eSTAR 5.0.
  • Interact and Engage: Participate in an insightful Q&A session where you can ask your questions and learn from others.

Watch the webinar

eSTAR 5.0 Are You Ready
Who should attend?
Regulatory affairs professionals and management as well as anyone who will have to work in the eSTAR template to build a submission.
Register Now  

Hosted by

Michelle Lott - white background
Presenter: Michelle Lott

Principal and Founder,

Michaela Kivett
Moderator: Michaela Kivett

Medical Device Guru,
Greenlight Guru


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About leanRAQA

leanRAQA specializes in regulatory strategy, submissions, quality systems and compliance, audit management, and more. The leanTeam acts as collaborators and strategic partners throughout the product and company lifecycle, from concept through commercialization and beyond! Visit their website to learn more.


About Greenlight Guru

Greenlight Guru is the #1 provider of modern cloud-based solutions for the MedTech industry, helping companies bring life-changing products to market faster, more efficiently, and with less risk. Greenlight Guru’s MedTech Suite provides quality management, product development, and clinical data management solutions, along with high-quality training and education required to keep up with the rapidly changing industry regulations. Trusted by over 1,100 medical device companies across the globe, Greenlight Guru has been named by G2 as the #1 Medical QMS Software and by the Inc Magazine as a Best Place to Work. For more information, visit our homepage.

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