Medical Device Lead Auditor Certification Course

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 and the auditing principles and guidelines of ISO 19011.

The course combines theoretical foundations with real-world industry experience through practical examples, case studies and hands-on exercises.

The course is sponsored by the Israeli Association for Quality and Innovation.

Course Details

Duration: 3 full training days
Dates: 13.01.2027, 20.01.2027 and 28.01.2027
Hours: 09:00–17:00
Location: gstudy Center, Haifa
Address: 4 Palmer Street, Portown 1 Building, 4th Floor, Downtown Haifa

What You Will Learn

• Performing first-party, second-party and third-party audits
• Audit planning
• Developing audit programs
• The art of questioning
• Audit communication techniques
• Applying ISO 13485:2016 and ISO 19011 requirements in practice

Course Materials

• Presentations and supporting materials
• Checklists and ready-to-use templates
• Personal guidance throughout the practical exercises

Certification

Participants will receive an official certificate under the auspices of the Israeli Association for Quality and Innovation.

The number of participants is limited to ensure personal attention and an interactive learning experience.