Navigating FDA Requirements-Quality & Regulatory Essentials for Medical Devices

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Date: Oct 28, 2026
By Avital Levertov
Registration
Regulatory Affairs Quality Assurance & Auditing
  • Location: Frontal
  • Duration: 1 Day
  • Starts at: 09:30
  • Language: Hebrew

FDA Requirements: Quality & Regulatory Essentials for Medical Devices – 1-Day Seminar

This seminar introduces 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.

Practical tips, reference links and interactive polls will help participants understand the content and apply it to their own products.


Course Details

Duration: 1 day
Date: 28.10.2026
Hours: 09:00–16:00
Location: gstudy Center, Haifa


What You Will Learn

  • Key medical device regulations
  • FDA regulatory pathways for 510(k) clearance, De Novo granting and PMA approval
  • Risk classification
  • FDA supportive programs
  • Practical application of the course content to participants’ products


This seminar is part of the full Medical Device Quality and Regulation Course

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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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