Lead Auditor
5 Days
ISO 13485 Lead Auditor
Develops the capacity to conduct medical device quality management system audits to international standards.
Duration
5 Days
Certificate
Exemplar Global
Format
Classroom / Online
Modules
4 Modules
Who Is This Course For?
Medical device quality managers
Regulatory auditor candidates
Certification auditors
Medical device consultants
Course Content
A comprehensive, modular curriculum designed for practical application
Module 1: ISO 13485 Structure
- Medical device regulations
- Risk management (ISO 14971)
- Design and development controls
Module 2: Special Requirements
- Sterilisation validation
- Traceability
- Vigilance reporting
Module 3: Audit Techniques
- Clean room auditing
- Production process verification
- Clinical evaluation review
Module 4: Reporting
- Regulatory findings reporting
- Corrective actions
- Market surveillance
Certification
The ISO 13485 Lead Auditor certificate qualifies you to independently conduct medical device quality system audits.
Medical device auditor certification
Regulatory compliance expertise
Risk management
Healthcare sector career
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