Quality & Safety Management

Medical Device Quality Management with ISO 13485

Course Details

About this course

Quality management is crucial in the medical devices industry to ensure the safety and efficacy of products that directly impact patient health. ISO 13485: Medical Devices Quality Management System provides a comprehensive framework for organizations involved in the design, production, installation, and servicing of medical devices. This course aims to equip participants with the knowledge and skills necessary to understand, implement, audit, and continually improve ISO 13485 QMS. Participants will explore the principles and requirements of ISO 13485, learning how to develop and maintain robust quality management systems that meet regulatory requirements and enhance product quality and safety.

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Summary

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Course

Medical Device Quality Management with ISO 13485

Duration

5 days

Course Code

GSM003

Location

Kuala Lumpur

Start Date

28 Sept 2026

Format

Classroom

Price

$3,600

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