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Regulatory Saturdays

Learn FDA medical device regulations through practical, hands-on weekend sessions designed for working professionals. Build real-world regulatory knowledge, strengthen your submission and compliance skills, and develop a solid foundation for professional certification exams.

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

Get a glimpse of what you’ll learn each week below. Want to see the hands-on side? Explore Learn by Practice for weekly activities, or dive into the

Program Breakdown Brochure for the complete course coverage.

Week 1 - FDA  legal frameworks, & Key concepts

Week 2 - Device Classification & Premarket pathways

Week 3 - 510(k) submissions & Pre Sub strategy 

Week 4 - De novo, PMA  & Electronic Submissions

Week 5 - QMSR, Clinical Evidence & Labeling 

Week 6 - Post market requirements & Vigilance 

  • 14+ hours of live training

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    Live demos & real-world MDR activities


     Hands-on EU-MDR assignments

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    6 quizzes (20 questions each)
     

    Guest lectures
     

    Certificate of Learning
     

    Missed a class? Live-Recordings provided

  • Content structured to support RAPS RAC-Devices exam prep*​

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    Personalized support & progress feedback

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    Questions? 20-Minute Post-Session Q&A

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    REGSTALK Connect! – Alumni collaboration community

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*Disclaimer: REGSTALK is not affiliated with RAPS in any way. All study materials, quizzes, and practice exams are independently developed and are solely intended to support learning the FDA Medical Device Regulation (EU-MDR).
These resources do not reflect the content, structure, or format of the official RAC exam and are not designed to replicate the exam. Their purpose is purely to help participants understand and apply the regulation.

Launching
Regulatory Saturdays - FDA Simplified!

Launch Price
$149 CAD (All inclusive)

Start Date

November 14, 2026

End Date

December 19, 2026

Mastery Session

December 20, 2026

Timings

Saturdays | 9 AM - 11AM (ET)

Student Offer

Get the course for a flat $85 CAD

Bring A Friend

Enroll together and save 15% each!

Referral Program

REGSTALK Alumni or Referred by One?

 

Enjoy 25% off!

How to Avail

Click “Chat Box” and request your discount code instantly.

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