Awareness Training Program on Medical Devices

Training duration: 1 Day

Course Overview

This program offers participants a comprehensive introduction to ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes). Gain essential insights into the key regulatory quality management standard for medical devices and understand its relationship with ISO 9001:2015. Learn about the critical issues addressed by ISO 13485 and how Risk Management according to ISO 14971 is integrated within the quality management system to enhance product safety and compliance.

What Will You Learn?

ISO 13485:2016 outlines the requirements for quality management systems specifically intended for medical device manufacturers, developers, and suppliers. This training helps you understand the development, implementation, and maintenance of robust QMS that meet both customer and applicable regulatory requirements.

Course Outline

• Basic Introduction to ISO 13485:2016
• Relationship between ISO 9001:2015 and ISO 13485:2016
• Key issues addressed by ISO 13485:2016
• Integration of Risk Management (ISO 14971) within ISO 13485

Who Should Attend?

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

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

Learning & Career Benefits 

• Gain a solid understanding of ISO 13485:2016 requirements for medical devices
• Learn how ISO 13485 relates and contrasts to ISO 9001:2015
• Understand the major quality and regulatory challenges addressed by ISO 13485
• Grasp the fundamentals of integrating risk management per ISO 14971 within your QMS

Examination & Certification 

This is a non-examination awareness program. Participants will receive a Certificate of Participation upon successful completion of the course.

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]