Certified Medical Device Management Systems Lead Auditor

Issued by Exemplar Global

Professionals who hold this certification are competent to conduct an audit of a Medical Device Management System as a solo auditor or to lead an audit team. They have completed an Exemplar Global-certified training course (or equivalent) and have also completed the Exemplar Global Work Style Assessment for Lead Auditors.

Type Certification
Level Intermediate
Time Days
Cost Paid

Additional Details

Skills

Earning Criteria

Certificate of successful completion of an Exemplar Global-certified Medical Device Management System Lead Auditor course from either a TPECS-certified training course (AU, TL, and MD/13485) or an equivalent Exemplar Global Recognized Training Provider (RTP) course.
Completion of the Exemplar Global Work Style Assessment for Lead Auditors.

Standards

ISO 13485:2016

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

ISO 19011:2018

This document provides guidance on auditing management systems, including auditing principles, managing an audit program, conducting management system audits, and guidance on the evaluation of competence of individuals involved in the audit process. These activities include the individual(s) managing the audit program, auditors and audit teams.