ISO 13485 Internal Auditor Training Program

virtual classes schedule

8th - 9th August 2024: ISO 13485 Internal Auditor Training | Time: 09:30 am to 05:30 pm I Duration: 2 days

24th - 25th August 2024: ISO 13485 Internal Auditor Training | Time: 09:30 am to 05:30 pm I Duration: 2 days

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

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

Pre-requisites

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.