Medical Device Quality and Regulation Course
Regulation
Quality Assurance
Starts at: 09:30
Duration: 5 meetings
Language: Hebrew
Essential Training in Quality and Regulatory Affairs for the Medical Device Industry
This course focuses on an in-depth understanding and practical implementation of quality standards, U.S. and EU medical device regulations, and risk management in the field. Through real-world case studies and hands-on exercises, you’ll gain the tools to understand requirements and meet them effectively.
The course provides a practical overview of the regulatory frameworks and quality requirements in both the U.S. and EU. Participants will work through exercises and examples that help clarify how to implement and comply efficiently with the regulatory landscape.
The U.S. and EU are the two leading global markets for medical devices, each with a unique regulatory system.
The ability to navigate both U.S. FDA and EU MDR requirements is a vital skill for professionals aiming to work in the medical device sector or bring a product to market in either region.
Medical Device Quality and Regulation Course Structure: Five Sessions
Session 1 – Quality Requirements
Session 2 – Quality Systems
Session 3 – U.S. Regulatory Affairs
Session 4 – EU MDR Regulatory Affairs
Session 5 – Risk Management
Course Details
🕘 Time: 09:30–15:30
📚 Academic Hours: 40 hours
📍 Location: Gstudy Training Center, Haifa – Matam Science Park
Course Dates
September 8, 2025
September 15, 2025
September 28, 2025
September 30, 2025
October 20, 2025
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 for registrations completed by July 1st, 2025
Who Are Your Instructors? Active Regulatory Professionals - Not Academic Theorists
5 intensive days, 40 contact hours with Gsap's senior project managers who have successfully implemented quality systems across 200+ medical device manufacturers
What You Get at the End?- Professional Confidence to Lead - Return to work with the ability to independently manage regulatory submissions, quality system implementations, and compliance assessments
- 4 Professional Training Certificates - Quality Management, US FDA Regulation, EU MDR Compliance, Risk Management (ISO 14971)
- Audit-Proven Templates - Ready-to-use documentation that has successfully passed ISO 13485, FDA, and Notified Body audits
- Precision Checklists & Resources - Complete presentation decks, step-by-step process guides, and comprehensive reference materials
About Dana Tirosh B.A.
Regulatory and Quality expert and a certified lead auditor (BSI Certified Lead Auditor - ISO 13485:2016 IRCA Certified) Experienced in establishing, implementing and maintaining a QMS, well familiar with international standards and regulations, audit management, project oversight and Global Regulatory Submissions. Successfully participated in many ISO 13485, EU and MDSAP Audits as the lead point of contact. Dana is...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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