Medical Device Lead Auditors Certification

Course Dates  :     29.12.25,  5.1.26, 12.1.26

09:00 – 17:00

Gstudy Training Center, Sha'ar Palmer Street 4, Portwon Building 1, Haifa.

• 3 full training days
• Practical exercises – audit plan preparation, the art of asking effective questions, communication during audits, and more
• Official certificate under the auspices of the Israeli Society for Quality
• Presentations, reference materials, checklists, and ready-to-use templates
• Personalized guidance during exercises
• Light refreshments, hot drinks throughout the day, and lunch

The course is led by Dana Tirosh, a senior expert in medical device regulation and quality, and a certified Lead Auditor.

Dana brings to the course a rare combination of deep regulatory expertise, extensive hands-on experience, and an inspiring instructional approach. She is certified by BSI and the Standards Institute of Israel as a Lead Auditor for ISO 13485 and ISO 27001. She has successfully guided dozens of companies in Israel and worldwide through ISO, MDR, and MDSAP audits.

She has extensive experience in establishing, implementing, and maintaining quality management systems, leading complex regulatory audits, and managing submissions to markets including Europe, the U.S., Brazil, Canada, and others. Throughout her career, Dana has conducted numerous audits-both as a Lead Auditor and as an Auditee-always focusing on practical, applicable solutions.

Participants in Dana’s courses describe her as a highly professional, focused, and engaging lecturer who makes complex regulatory topics accessible and clear, combining real-life examples and audit simulations that reflect actual industry challenges. They highlight her direct approach, her ability to connect theory with practice, and her personal commitment to supporting each participant.

Dana is widely recognized as someone who “doesn’t just teach - she trains professionals.” Her energy, humor, and professionalism turn every training day into an enriching and empowering experience.