Medical Device Quality and Regulation Training Course – Full
Gstudy > Courses and seminars > Medical Device Quality and Regulation Training Course – Full
Regulation
Quality Assurance
Location: Frontal
Starts at: 09:30
Duration: 5 meetings
Language: Hebrew
Medical Device Quality and Regulation Course
This comprehensive 5-day course provides in-depth knowledge and practical skills on Medical Device Quality Management Systems and Regulatory Requirements. Participants will learn how to establish and maintain effective quality systems while ensuring compliance with key regulations in major markets. Throughout the course, participants will engage in interactive discussions, case studies, and practical exercises to reinforce learning and develop skills in applying quality and regulatory requirements to real-world scenarios in the medical device industry.Session 1 – Quality Requirements - 14.10.26
Session 2 – Quality Systems - 21.10.26
Session 3 – U.S. Regulatory Affairs - 28.10.26
Session 4 – EU MDR Regulatory Affairs- 4.11.26
Session 5 – Risk Management - 11.11.26
Time: 09:30–15:30
Academic Hours: 43 hours
Location: Gstudy Training Center, Haifa
Flexible Registration Options Available - Complete Program or Individual Modules
Choose the full 5-day certification track or select specific regulatory focus areas
Early Bird Savings: 10% discount
About Sivan Luder, PhD
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, managing regulatory projects, and preparing...
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Registration Information
Early Bird Discount: 30 days in advance
Group Rates: Available for 3+ participants
Corporate Training: Custom programs for 8+ participants
Contact: Gstudy@gsap.co.il