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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.

  • 12+ hours of live training
     

    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

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

Nothing to book right now. Check back soon.
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