ISO 13485 Lead Auditor Training

Master the Art of Auditing Medical Device Quality Management Systems

Our ISO 13485:2016 Lead Auditor Training is a comprehensive course that equips participants with the skills and qualifications to audit Medical Device Quality Management Systems (MDQMS) in accordance with ISO 13485 standards and the guidelines of ISO 19011 and ISO/IEC 17021.

Designed for professionals in the medical device industry, this training prepares you to lead audits that ensure compliance with international regulatory and quality requirements.

Key Learning Objectives

• In-depth understanding of ISO 13485:2016 standard

• Structure and requirements of MDQMS

• Risk-based thinking in medical device manufacturing

• Principles and techniques of auditing

• Audit planning, execution, reporting & follow-up

• Performing audits based on ISO 19011 guidelines

• Regulatory relevance with MDR, FDA 21 CFR Part 820, and more

Who Should Attend?

• Quality Managers & Regulatory Affairs Professionals

• Internal Auditors in Medical Device Companies

• Compliance Officers and Quality Assurance Teams

• Consultants and Certification Body Auditors

• Anyone aspiring to become a certified ISO 13485 Lead Auditor

Certification & Recognition

Successful candidates will receive an internationally recognized ISO 13485:2016 Lead Auditor Certificate from an accredited certification body. This qualification allows you to lead internal, supplier, and third-party audits for medical device quality systems.

Training Details

• Duration: 5 Days

• Format: Classroom / Live Online / On-Site Training

• Trainer: Certified auditors with medical device industry expertise

• Materials: Course manual, audit checklist templates, real-life case studies

• Evaluation: Written exam + continuous assessment during training

Why Choose Our Training?

• Globally recognized and accredited training provider

• Expert trainers with regulatory and audit experience

• Industry-focused examples for practical understanding

• Custom training available for device manufacturers and suppliers

• Post-training audit tools and guidance provided