Sodick & Friends Workshop: Medical Device Design &
Development Regulations
Boot Camp
Development Regulations
Boot Camp
October 28-30, 2025
9AM-4PM
Plustech Inc.: 111 NW Point Blvd, Elk Grove Village, IL 60007
9AM-4PM
Plustech Inc.: 111 NW Point Blvd, Elk Grove Village, IL 60007
The U.S. medical device regulatory landscape is complex—and always evolving. Whether you’re new to the field or need a comprehensive refresher, the Medical Device Bootcamp will equip you with the knowledge and tools to confidently navigate regulations and bring your medical devices to market successfully.
This fast-paced, three-day program combines concise lectures, real-world case studies, and interactive exercises to help you:
→ Navigate Regulatory Pathways: 510(k), De Novo, PMA, IDE approvals made clear.
→ Build Compliant Systems: Align with Design Control, QSR/QMSR, and ISO 13485.
Generate Credible Evidence: Clinical data, human factors, and usability studies demystified.
→ Stay Ahead of Change: Insights on combination products, IVDs, EU MDR contrasts, software, and AI/ML-enabled devices.
This fast-paced, three-day program combines concise lectures, real-world case studies, and interactive exercises to help you:
→ Navigate Regulatory Pathways: 510(k), De Novo, PMA, IDE approvals made clear.
→ Build Compliant Systems: Align with Design Control, QSR/QMSR, and ISO 13485.
Generate Credible Evidence: Clinical data, human factors, and usability studies demystified.
→ Stay Ahead of Change: Insights on combination products, IVDs, EU MDR contrasts, software, and AI/ML-enabled devices.
WHY ATTEND?
Dr. Rahul R. Panchal, Founder and CEO of Leonine Technologies Inc., has decades of experience guiding companies through regulatory strategy, compliance, and successful device commercialization. His practical insights will help you implement what you learn right away.
Pricing & Registration:
We offer flexible pricing options to make it easy to secure your spot:
→ Standard Registration: $2,500
→ Early Bird Discount: $2,200 if you register by October 17
Your registration includes:
→ Daily Catered Lunch
→ Three full days of training with Dr. Rahul R. Panchal
→ Workshop materials and templates for immediate use
→ Access to all case studies, lectures, and hands-on sessions
→ Networking opportunities with industry peers and experts
→ Standard Registration: $2,500
→ Early Bird Discount: $2,200 if you register by October 17
Your registration includes:
→ Daily Catered Lunch
→ Three full days of training with Dr. Rahul R. Panchal
→ Workshop materials and templates for immediate use
→ Access to all case studies, lectures, and hands-on sessions
→ Networking opportunities with industry peers and experts
Location
15 Minutes from O'Hare Airport
Plustech Inc.
111 NW Point Blvd, Elk Grove Village, IL 60007
Plustech Inc.
111 NW Point Blvd, Elk Grove Village, IL 60007