Medical Device Quality and Regulation Training Course – Full

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Date: Oct 12, 2026
By Sivan Luder & Dana Manaim-Tirosh & Avital Levertov
Registration
Regulatory Affairs Quality Assurance & Auditing
  • Location: Frontal
  • Duration: 5 Days
  • Starts at: 09:30
  • Language: Hebrew

Medical Device Quality and Regulation Course

Registration for the first two seminar days is now closed
Registration is still open for the remaining three days

This comprehensive course provides in-depth knowledge and practical skills in Medical Device Quality Management Systems and Regulatory Requirements.

Through interactive discussions, case studies and practical exercises, participants will learn how to establish and maintain effective quality systems, ensure compliance with key regulations in major markets and apply quality and regulatory requirements to real-world scenarios in the medical device industry.

Course Details

Duration: 5 days | 43 academic hours
Dates:

  • Session 1 – Quality Requirements | 12.10.2026
  • Session 2 – Quality Systems | 21.10.2026
  • Session 3 – U.S. Regulatory Affairs | 28.10.2026
  • Session 4 – EU MDR Regulatory Affairs | 04.11.2026
  • Session 5 – Risk Management | 11.11.2026

Hours: 09:30–15:30
Location: gstudy Center, Haifa
Registration Options: Complete Program or Individual Modules

What You Will Learn

  • Medical Device Quality Management Systems
  • Regulatory requirements in major markets
  • Establishing and maintaining effective quality systems
  • Applying quality and regulatory requirements to real-world scenarios

Participants may choose the complete five-day certification track or select specific regulatory focus areas

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Sivan Luder

Dr. Sivan Luder is a Regulatory, Clinical, and Quality Expert with a PhD in Molecular Biology and over 10 years of experience across various industries, with a strong focus on the medical device sector. Possesses a deep scientific background and extensive experience in leading the development and implementation of medical devices from concept to commercialization, […]
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Dana Manaim-Tirosh

Dana brings to the Gstudy Training Center over a decade of professional experience in the medical-device industry, leading complex quality and regulatory projects while combining her capabilities in developing and building innovative learning frameworks with hands-on field experience. As an instructor, course developer, and training leader, she designs and delivers specialized training programs in quality […]
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Avital Levertov

Senior Regulatory Affairs Expert for Medical Devices in the U.S. Market, Project Manager, and Lecturer at GSAP. Avital brings over 14 years of proven experience in the medical device industry, specializing in U.S. medical device regulations, with hands-on experience in a wide range of FDA interactions, including: Premarket applications submitted via eCOPY and eSTAR Pre-submissions […]
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