17 - 18 October 2023
2-Day Webcast Serieskeyboard_arrow_right
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Day 1 - 17 October 2023
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Day 1 - 17 October 2023
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14:00 - 15:00Free
Crossing the eSTAR Chasm: How to Transition to FDA’s Mandatory 510(k) eSTAR submission process
This session 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.
- Soumya Mahapatra - CEO, Essenvia
- Dhriti Roy - VP of Regulatory Affairs Transformation, Essenvia
15:00 - 16:00Free
Navigating Regulatory Affairs and Ensuring Compliance in a Medtech scale up
Key takeaways:
- How to enhance your Certification Strategy: Best practices and proven methods
- What you need to implement an effective strategic planning structure to ensure compliance
- Best practices to become certified faster
- Ann Vankrunkelsven - RA/QA Manager, Matrix Requirements
16:00 - 17:00Free
EUDAMED: Where Are We Now?