12+ hours of live training
Live demos & real-world MDR activities
Hands-on EU-MDR assignments
6 quizzes (20 questions each)
2 practice tests (120 questions each)
Guest lectures
Certificate of Learning*
Missed a class? Recording provided
​Extended access to materials
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RegStalk Connect! – Alumni collaboration community
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Personalized support & progress feedback
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Content structured to support RCC-MDR exam prep*
Upcoming Batch
Batch 4 - EU-MDR Simplified!
Price Details
$99 CAD
Start Date
September 19, 2026
End Date
October 24, 2026
Mastery Session
October 25, 2026
Timings
Saturdays | 9 AM - 11AM (ET)
Student Offer
Get the course for a flat $75 CAD
Bring A Friend
Enroll together and save 5% each!
Referral Program
Referred by a REGSTALK alumni ? Get 5% off!
How to Avail
Click “Let’s Chat” and request your discount code instantly.
Program OVERVIEW
Each week explores the topic through guided instruction, practical examples, discussions, and regulatory insights. A brief 6-week overview is provided below. Detailed coverage is available in the Program Breakdown Brochure
Week 1 - FDA legal frameworks, & Key concepts
Week 2 - Device Classification & Premarket pathways
Week 3 - 510(k) submissions, Pre Sub strategy and FDA Communication
Week 4 - De novo, PMA & Clinical Pathways
Week 5 - QMSR, Clinical Evidence & Labeling Compliance
Week 6 - Post market requirements, Vigilance a& FDA Inspections

