FREE ON-DEMAND WEBINAR
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.