Medical Device ISO 13485 Quality Management System Requirements Training
Gstudy > Courses and seminars > Medical Device ISO 13485 Quality Management System Requirements Training
Quality Assurance
Regulation
Location: Frontal
Starts at: 09:00
Duration: 2 Days
Language: Hebrew
This comprehensive two-day course provides in-depth knowledge and practical skills for implementing and maintaining ISO 13485:2016 Quality Management Systems in medical device organizations. Participants will gain essential competencies in establishing effective quality systems while ensuring regulatory compliance across major global markets. The course emphasizes practical application through interactive discussions, case studies, and real-world exercises, enabling participants to immediately apply ISO 13485 requirements to their organizational contexts.
Two-day intensive course | 14.10.26 + 21.10.26 | 09:00-16:00 18.5 academic hours | Location: Haifa
Learning Objectives:
Upon completion of this course, participants will be able to understand ISO 13485:2016 requirements and their practical application.Who Should Attend
Professionals working in the medical device industry, including Quality, Regulatory, R&D, Manufacturing, Engineering, and Clinical teams.Prerequisites
- Basic understanding of medical device industry
- Familiarity with regulatory concepts (helpful but not required)
- Experience in quality or manufacturing environments (preferred)
Course Materials Included
- 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 receive a Certificate of Completion Early Bird: 10% Register 30 days in advance Group Discounts: Available for 2+ participants from the same organization- Course fee includes all materials, refreshments, and certification
About 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 and regulatory affairs in the...
Contact Us
תודה על הרשמתך לקורס
אנו נצור עמך קשר על מנת להשלים את תהליך הרישום
בנתיים שלחנו פרטים למייל שהזנת
Comments
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