ISO 13485 Internal Auditor Training Program

Based on ISO 13485:2016 Standard - Medical Device Quality Management Systems

Based on ISO 13485:2016 Standard - Medical Device Quality Management Systems

virtual classes schedule

27th - 28th Aug 2022: ISO 13485 Internal Auditor Training | Duration: 2 Days I Time: 09:30 am to 05:30 pm

Note: If your preferred training date is not visible, please reach out to us by filling up the form.

What you'll gain by enrolling for this course?

  • Internationally accepted ISO 13485 Internal Auditor Training Certificate
  • ISO 13485 Training Kit and Pre-study material
  • Improve your understanding about developing safe and effective medical devices
  • Understand how you can better meet regulatory requirements leading to increased patient safety


The number of connected medical devices and the development of digital healthcare applications has been growing rapidly. Failing to ensure medical device cybersecurity could lead to significant reputational damage for device manufacturers and healthcare organizations that use insecure technology. 

TÜV SÜD’s free on-demand webinar will help you understand the significant elements related to cybersecurity in Medical Devices. To watch the webinar, click on the below link:

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About the course

The ISO 13485:2016 Internal Auditor Training Course aims to provide knowledge about all the requirements of 13485:2016 standard to help you implement, audit a Medical Device Quality Management System. Professions who complete this course will be able to successfully perform internal audit activities and use the knowledge gained to offer corrective measures for Medical Device Quality Management processes.

Training Duration

2 Days


Who should attend?

  •  Medical Device Manufacturers
  • Quality Professionals
  • Regulatory Professionals
  • Internal and external Auditors
  • Consultants and anyone involved with the implementation of the standard

Learning and Career Benefits

  •  Understand the requirements of ISO 13485:2016, a standalone Quality Management Systems standard for Medical Device manufacturers that is mandatory while fulfilling the regulatory compliance
  • Learn to perform internal auditor activities and evaluate your organization’s Medical Device Quality Management System
  • Learn about the Guidelines of Medical Device Quality Management System auditing according to ISO 13485:2016


Having prior knowledge and understanding of the Quality Management System - ISO 13485 Standards and/or experience in medical device operations.

Examination and Certification

Written examination(Open Book) will be conducted at the end of the course. Participants who score 70% and above will be issued a Certificate of Achievement, while the others will be issued a Certificate of Attendance.

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Contact us for your ISO 13485 Internal Auditor training requirement. 

Email    :   training[email protected]


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