Successfully navigating the IDE pathway requires more than technical knowledge — it demands a clear regulatory strategy, strong documentation, and effective engagement with FDA. That’s why AdvaMed is bringing together leading FDA and industry experts for a focused, practical IDE Submissions Workshop on February 25 online.
This full-day program is designed for regulatory, clinical, and product teams looking to build stronger IDE applications from preclinical preparation through study approval, while advancing their professional expertise and earning up to 6 RAPS accreditation credits. Join us and invest in your organization’s regulatory expertise!
Learn Directly From FDA and Regulatory Leaders
Through expert-led sessions and practical insights, attendees will learn how to develop stronger, more effective IDE submissions and best practices for engaging with FDA throughout the IDE lifecycle. View the agenda to preview the topics you’ll explore. If you’re looking to elevate your IDE strategy, two sessions I strongly recommend include:
1. Regulatory Compliance During Study Conduct
- Monitoring
- Consenting of patients
- Enrollment requirements
- Adverse event reporting
- Sponsor records and reports
- Investigator records and reports
- Protocol deviations
Speaker
Tony Blank, Senior Director of Regulatory Affairs, AtriCure
2.BIMO Inspections
- The purpose of a BIMO inspection
- When and how a BIMO inspection occurs
- Preventing findings and responding to findings
- Typical and atypical observations – cautionary tales from the field
Speaker
Amrin Chowdhury, Health Scientist, FDA
Invest in Your Regulatory Expertise
Don’t miss this valuable chance to strengthen your IDE expertise and connect with FDA and industry leaders. I encourage you to explore the Workshop program and share this opportunity with colleagues who are strengthening their IDE capabilities or looking to advance their professional accreditation.
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