Description

This package includes official registration for the PECB ISO 13485 Lead Auditor exam, together with comprehensive training materials. It is designed for professionals who want to develop the expertise to perform Medical Devices Quality Management System (MDQMS) audits by applying widely recognized audit principles, procedures, and techniques.

Ideal for those who want to master audit planning, execution, and reporting, while building the competence to lead audit teams and ensure conformance with ISO 13485 requirements and global best practices.

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What’s Included:

Official PECB ISO 13485 Lead Auditor exam registration
Full training course materials with case studies, exercises, and quizzes
Digital resources for self-study and exam preparation
1-year exam validity
Free second exam attempt if needed
Online exam format – take it from anywhere, anytime via PECB Exams

Why Choose This Package?

Gain knowledge and skills to perform internal and external MDQMS audits in compliance with ISO 19011 and ISO/IEC 17021-1
Master audit techniques and learn how to manage an audit program, audit team, and communication with clients
Understand the operations of an MDQMS and the correlation between ISO 13485 and other regulatory frameworks
Learn how to interpret ISO 13485 requirements in the context of auditing medical device organizations
Prepare effectively for certification with practical exercises, role-playing, and practice tests

Who Is This For?

Auditors seeking to perform and lead MDQMS certification audits
Managers and consultants mastering the medical devices audit process
Professionals responsible for maintaining MDQMS conformity in their organizations
Technical experts preparing for ISO 13485 audits
Advisors in medical device quality management
Anyone aiming to earn the globally recognized ISO 13485 Lead Auditor certification