This badge was issued to Richard Litts on 13 Mar 2024.
Expires on 12 Apr 2025- Type Certification
- Level Intermediate
- Time Days
- Cost Paid
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
Earning Criteria
Standards
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.
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.