Medical Device ISO 13485 Quality Management System Requirements Training – The course is fully booked

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Date: Oct 12, 2026
By Dana Manaim-Tirosh
Registration
Quality Assurance & Auditing Regulatory Affairs
  • Location: Frontal
  • Duration: 2 Days
  • Starts at: 09:00
  • Language: Hebrew

ISO 13485:2016 Quality Management Systems Course

The course is fully booked

This comprehensive course provides in-depth knowledge and practical skills for implementing and maintaining ISO 13485:2016 Quality Management Systems in medical device organizations.

Through interactive discussions, case studies and practical exercises, participants will learn how to establish effective quality systems, meet regulatory requirements across major global markets and apply ISO 13485 requirements within their organizations.

Course Details

Duration: 2 days | 18.5 academic hours
Dates: 12.10.2026 and 21.10.2026
Hours: 09:00–16:00
Location: Haifa

What You Will Learn

Upon completion of the course, participants will understand ISO 13485:2016 requirements and their practical application.

Who Should Attend?

Professionals working in the medical device industry, including:

  • Quality and Regulatory
  • R&D and Engineering
  • Manufacturing
  • Clinical teams

Prerequisites

  • Basic understanding of the medical device industry
  • Familiarity with regulatory concepts is helpful but not required
  • Experience in quality or manufacturing environments is preferred

Course Materials

  • Comprehensive course handbook with templates and checklists
  • ISO 13485:2016 implementation toolkit
  • Case study materials and exercises
  • Access to regulatory update resources
  • Professional networking opportunities

Certification

Participants will receive a Certificate of Completion.

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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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