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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 - EU-MDR Essentials: Structure, key players & Core concepts
Week 2 - Classification & Conformity Assessment Foundations
Week 3 - Selecting the Conformity Assessment Route
Week 4 - Clinical Evaluation & EU Registration systems
Week 5 - Clinical Evaluation & EUDAMED
Week 6 - Post-Market Surveillance
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
RegStalk Connect! – Alumni collaboration community
Personalized support & progress feedback
Content structured to support RCC-MDR exam prep*
*Disclaimer: REGSTALK is not affiliated with RAPS or the RCC-MDR certification in any way. All study materials, quizzes, and practice exams are independently developed and are solely intended to support learning the EU Medical Device Regulation (EU-MDR).
These resources do not reflect the content, structure, or format of the official RCC-MDR exam and are not designed to replicate the exam. Their purpose is purely to help participants understand and apply the regulation.
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.
Ended
CAD99
"I would describe this session as very insightful and practical for understanding the EU MDR requirements. Over the 6-week EU-MDR program, I gained a clearer understanding of key regulatory concepts such as GSPRs, clinical evaluation, and post-market requirements.
The key takeaway not to miss is how all elements like risk management, clinical evidence, and post-market surveillance are interconnected and essential for ensuring device safety and compliance throughout its lifecycle."
Kruti Patel
QA Specialist, Gilead, US
"I have gained focused insights on EU MDR that clarified my doubts and sharpened and strengthened my understanding.
This session showed me how complex regulatory concepts can be transformed into clear actionable insights, which I can apply in my professional work."
Bhanu Prakash Maheshwar
Senior Technical Lead, HCL Tech, India
"A basic understanding from scratch of the EU-MDR, with a good breakdown of key points; also helpful for RAC exam prep."
Mithila Mhapankar
Regulatory Content Strategist - Drugs, Roche, Canada
"The presentations are very clear and condensed, which makes learning and navigating the EU MDR so much easier compared to reading the regulation on its own. It really helped me build a strong overall understanding of the MDR and was especially useful in preparing for exams. I also found the weekly quizzes—though I did them open book—very thoughtfully designed. The questions went beyond simple recall and made me stop, think, and apply what I had just read, which really reinforced the learning."
Manisha Kannaiya
RA Graduate Student, Northeastern University, Canada
"Before I joined this session, I had a very basic level of EU-MDR regulations. Now I can confidently tell that I have a very good understanding of regulations. Explaining it by dividing the topics and providing supplementary material, slides, recordings, and quizzes is really helpful"
Deepthi Sharabu
Quality Regulatory specialist, Medical University of South Carolina, US
"This session is very useful, I learned a lot about EU MDR regulation. I would definitely recommend this session to everyone who wants to understand EU MDR regulation and also to people who want to take RCC MDR examination."