Medical Device Lead Auditors Certification
Oct 22, 2025
By Dana Manaim – Tirosh
0.7
Quality Assurance
Engineering & Validation
Audits
Starts at: 09:30
Duration: 3 Sessions
Language: Hebrew
Gsap Certification Training Course Accredited by ISQ - Israel Society for Quality
This comprehensive training equips participants with the expertise to effectively evaluate medical device quality management systems against ISO 13485:2016 requirements. Participants will master audit techniques aligned with ISO 19011:2018 guidelines, from preparation through execution and reporting.
Designed for quality management system auditors and professionals leading organizational ISO 13485 conformance activities. Ideal for individuals involved in their organization’s internal auditing process who wish to expand their understanding of the comprehensive audit process. Recommended for anyone heavily involved in supplier quality assurance activities. This course is invaluable for: • Quality professionals responsible for conducting and leading medical device QMS audits • Personnel managing internal quality system compliance programs • Quality engineers and managers oversee vendor quality systems • Professionals seeking to enhance their auditing capabilities in the medical device industry
Days 1-3: 9:00 – 17:00 (including daily assessments and Final Exam) 22.10.25 26.10.25 29.10.25 Location : HaifaAbout Dana Manaim – Tirosh
Dana Tirosh - Head of the Gstudy Training Center, Senior Project Manager in Quality & Regulatory Affairs for Medical Devices 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...
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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