Medical Device Lead Auditor Certification Course
Gstudy > Courses and seminars > Medical Device Lead Auditor Certification Course
Quality Assurance
Regulation
Location: Frontal
Starts at: 09:00
Duration: 3 מפגשים
Language: Hebrew
Medical Device Lead Auditors Certification Course
The objective of this course is to provide participants with the knowledge and practical skills required to perform first-party, second-party, and third-party audits of a Quality Management System in accordance with ISO 13485:2016, following the auditing principles and guidelines of ISO 19011. The course integrates solid theoretical foundations with extensive real-world experience, bringing industry practice into the classroom through practical examples, case studies, and hands-on exercises. The course is sponsored by the Israeli Association for Quality and Innovation.Course Details
Dates: Jan 13, 2027 | Jan 20, 2027 | Jan 28, 2027 Hours: 09:00-17:00 Location: GSTUDY Training Center, 4 Palmer Street, Portwon 1 Building, 4th Floor, Downtown Haifa Three full training daysWhat the Course Includes
- Practical workshops: audit planning, developing audit programs, the art of questioning, audit communication techniques, and more
- Official certificate under the auspices of the Israeli Association for Quality
- Presentations, supporting materials, checklists, and ready-to-use templates
- Personal guidance throughout the practical exercises
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...
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