Medical Device Lead Auditor Certification Course
Gstudy > Courses and seminars > Medical Device Lead Auditor Certification Course
Quality Assurance
Regulation
Audits
Location: Frontal
Starts at: 09:00
Duration: 3 Days
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: June 17, 2026 | June 24, 2026 | July 01, 2026 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
Course Instructor – Dana Tirosh
The course is delivered by Dana Tirosh, Senior QA/RA Expert in Medical Devices and Lead Auditor. Dana brings a rare combination of deep regulatory expertise, hands-on industry experience, and inspiring teaching ability. She is certified to conduct ISO 13485 and ISO 27001 audits by BSI and the Standards Institution of Israel, and has successfully led dozens of companies in Israel and worldwide through ISO, MDR, and MDSAP audits. She has extensive experience in establishing, implementing, and improving Quality Management Systems, managing complex regulatory audits, and supporting regulatory submissions to Europe, the United States, Brazil, Canada, and additional markets. Throughout her career, she has led numerous audits both as an auditor and as a consultant supporting audited organizations – always with a strong focus on practical, implementable solutions. Training Participants consistently describe Dana as professional, focused, clear, and highly engaging. She is known for making complex regulatory topics accessible and understandable, using real-life examples and realistic simulations that reflect actual audit environments. Her direct approach, ability to connect theory with practice, and personal commitment to each participant are repeatedly highlighted. Many graduates report that the course significantly strengthened their professional confidence and upgraded their ability to lead audits effectively. Dana is known not only for teaching, but for truly training professionals. Her energy, professionalism, and sense of perspective turn every training day into a meaningful and empowering experience.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
