Internal Auditor Training Program on Medical Devices

Training duration: 2 Days

Course Overview 

This training program is designed to provide participants with a thorough understanding of implementing the ISO 13485:2016 Quality Management System (QMS) tailored for medical device manufacturers. Learn how to better meet regulatory requirements, contributing to increased patient safety and the development of safe and effective medical devices. Gain insights into both the requirements of ISO 13485:2016 and best auditing practices to ensure your organization’s compliance and continual improvement.

What Will You Learn?

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 standard applies to manufacturers, developers, and suppliers of medical devices, focusing on regulatory compliance and quality assurance. 

Course Outline 

• Module 1 – ISO 13485:2016 Requirements (Day 1) 
  Gain a comprehensive understanding of the ISO 13485:2016 standard, a standalone quality management system specific to medical device manufacturers, essential to meet regulatory compliance. 
• Module 2 – Auditing Techniques (Day 2) 
  Learn fundamental auditing concepts, including audit planning, execution, and reporting, based on ISO 19011. This module concludes with a written examination to evaluate your understanding.

Who Should Attend? 

• Medical Device Manufacturers
• Quality Professionals
• Regulatory Professionals
• Internal and External Auditors
• Consultants
• Anyone involved in the implementation or management of ISO 13485 

Pre-requisites: Basic knowledge of Quality Management Systems (ISO 13485) or experience in medical device operations is preferred but not mandatory. 

Learning & Career Benefits 

• Master the implementation of ISO 13485:2016 Quality Management System
• Enhance your ability to meet regulatory requirements, ensuring higher patient safety
• Facilitate development of safe, effective medical devices
• Acquire skills to conduct internal audits effectively
• Strengthen compliance and continuous improvement within your organization

Examination & Certification 

Upon completing the training, participants will take an examination. Those scoring 70% or above will receive TÜV SÜD South Asia’s Internal Auditor Certificate. Candidates who do not pass will be awarded a certificate of attendance.

Get in touch with us to know more.

Business address 

TÜV SÜD Bangladesh (Pvt.) Ltd.

Update Tower, Level- 12, 8 & 14, 01 Shahjalal Avenue, Sector-06, Uttara Model Town, Dhaka-1230, Bangladesh

Tel: +88 02 58954115, 58954120, Ext-119

Email: [email protected]