-
Duration
2.5 days
-
Expert instructors
1
-
Participants
20
Exclusive FDA Clearance 3-day Bootcamp
Advanced Insights for Medical Device Success
Location:
9330 Scranton Road
San Diego, CA 92121
*Further Detailed Below
Discount Pricing for a Limited Time, offer ends September 30th.
December 4 - 8:00 AM to 4:00 PM (Pacific Time) - Lunch provided
December 5 - 8:00 AM to 4:00 PM (Pacific Time) - Lunch provided
December 6 - 8:00 AM to 12:00 PM (Pacific Time)
Location:
9330 Scranton Road
San Diego, CA 92121
*Tentative Agenda:
- Understanding FDA Regulations
- Defining the Best FDA Clearance Strategy
- Navigating the FDA Submission Process
- Showing Clinical Efficacy and Performance
- Patient Safety and Risk Management
- Special Considerations – Cybersecurity, AI, SaMD, etc
- Quality Management Systems and FDA Compliance
- Labeling and Promotional Material
- Effective FDA Submission and Correspondence
- Post-Market Surveillance and Reporting
- International Regulatory Considerations
*Further Detailed Below
Discount Pricing for a Limited Time, offer ends September 30th.
— What's included
Master FDA medical device clearance with hands-on training from top experts, exclusive networking, and real-world applications.
Our bootcamp provides a comprehensive, high-value experience that goes beyond basic training. Whether you’re looking to refine your regulatory strategy, gain insights from leading experts, or collaborate with other professionals, this bootcamp equips you with the knowledge and skills needed to excel in the FDA clearance process and achieve your medical device goals.
Collaborative and Real-World Application
The bootcamp emphasizes hands-on learning and practical application through interactive workshops and case studies. Participants will work on real-world scenarios, applying FDA clearance strategies and solving complex regulatory challenges in a collaborative setting. This approach ensures that attendees not only understand theoretical concepts but also gain practical experience in navigating the FDA submission process, equipping them with actionable skills to tackle their own regulatory projects.
Expert Instructors
Our bootcamp features top industry experts with extensive experience in FDA medical device regulations. Led by seasoned professionals who have guided numerous companies through the FDA approval process, participants will gain invaluable insights from those who know the regulatory landscape inside and out. These instructors bring a wealth of knowledge, real-world examples, and practical advice, ensuring that attendees receive the highest level of expertise and guidance tailored to their needs.
Peer Group Support
Attendees will join a select group of like-minded professionals and industry leaders, fostering a dynamic and engaging learning environment. Networking with peers who share similar goals and challenges provides opportunities for valuable exchanges of ideas and experiences. This collaborative atmosphere not only enhances the learning experience but also builds connections that can support ongoing professional development and partnerships beyond the bootcamp