Medical Device Lead Auditors Course
Jan 22, 2025
By Dana Tirosh B.A.
Cycle 5.0
Quality
Audits
Regulatory
Starts at: 09:30
Duration: 4 Meetings
Language: Hebrew
Lead Auditor Training Course in Medical Device Quality Management Systems
Including Comprehensive Understanding and Practical Application of Audit Stages
Course Objective:
To provide the necessary knowledge and skills to conduct first, second, and third-party audits of a Quality Management System (QMS) in accordance with ISO 13485:2016, following the guidelines of ISO 19011.
This course brings real-world experience and industry practices directly into the classroom through numerous examples, case studies, and hands-on exercises.
The certificate is recognized by the Israeli Society for Quality.
Course dates:
22.1.25
27.1.25
29.1.25
Course Hours - 09:00-17:00
Location - Building 22 Matam Park, Haifa
Price - 4,000 NIS + VAT
Discounted price for early registration- 3,600 NIS+VAT
About Dana Tirosh B.A.
Regulatory and Quality expert and a certified lead auditor (BSI Certified Lead Auditor - ISO 13485:2016 IRCA Certified) Experienced in establishing, implementing and maintaining a QMS, well familiar with international standards and regulations, audit management, project oversight and Global Regulatory Submissions. Successfully participated in many ISO 13485, EU and MDSAP Audits as the lead point of contact. Dana is...
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Comments
The course aim is to provide the knowledge and skills required to perform 1st 2nd 3rd party audits of QMS’s to verify compliance with ISO13485:2016 and 21CFR820; under ISO 19011:2018, ISO 17021-1:2015.