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ISO 13485 Training

This standard is a cornerstone for quality management in the medical device industry. Our training program covers the core principles and practices required for compliance with ISO 13485, focusing on the development and maintenance of a robust quality management system. Participants will gain a a deep understanding of how to ensure product safety, efficacy, and compliance with regulatory requirements.

Anchor ISO 13485

Course Objectives

At the end of the presentation participants should be able to do the following:
•    Understand the philosophy and principles of Quality Management System (QMS) for Medical Devices.
•    Aware of Fundamental concepts and QMS Requirements of the overall activities carried out by the facility.
•    Understand the key factors and the importance of developing the QMS for the organization.
 

Course Outline

Overview of QMS For Medical Devices

 

  • Introduction

  • History and background of changes

  • Important point in ISO 13485:2016

 

Key Factor of QMS for Medical Devices

 

  • Introduction of ISO 13485:2016

  • Walk through the clauses of ISO 13485:2016

Target Audience

This program is very useful to participants who handles and are actively involved in Quality especially those who are QA/QC Lab technician, and QA/QC Executive.

Duration

2 full-day course. Physical Training (On-site).

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