Navigating FDA Requirements-Quality & Regulatory Essentials for Medical Devices
Gstudy > Courses and seminars > Navigating FDA Requirements-Quality & Regulatory Essentials for Medical Devices
Regulation
Quality Assurance
Location: Frontal
Starts at: 09:30
Duration: 1 Meeting
Language: Hebrew
FDA Requirements: Quality & Regulatory Essentials for Medical Devices - 1-Day Seminar
The seminar will focus on introducing the key medical device regulations, the main FDA regulatory pathways for 510(k) clearance, De Novo granting, or PMA approval based on risk classification, and the FDA’s supportive programs.
It will be accompanied by practical tips and reference links to help participants apply the material covered to their own products, as well as interactive polls designed to sharpen participants’ understanding throughout the course.
28.10.26 | 09:00-16:00 | Haifa
About Avital Levertov, MA
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 FDA inspections and responses to...
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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