Introduction
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.
Course Outline
- Module 1
- Module 2
- Module 3
- Module 4
- Module 5
- Course Objectives
- Target Audience
Introduction to ISO 13485
- Quality management principles and the role of ISO 13485.
- The structure and key requirements of ISO 13485.
- Quality management system in the medical devices industry.
- Establishing the scope of QMS and conducting gap analysis.
Responsibility and resource management
- Management commitment and leadership.
- Resource management, including human and infrastructure.
- Competence, awareness, and training.
Product Realization & Risk Management
- Planning and control of product realization processes.
- Design and development planning.
- Risk management and mitigation strategies.
Measurement, Analysis, & Improvement
- Monitoring and measurement of processes and products.
- Control of nonconforming products and corrective action.
- Internal audit principles and practices for QMS.
Auditing in the Medical Device Industry
- Internal audit process for ISO 13485 compliance.
- Regulatory audits and inspections.
- The future of quality management in the medical device industry.
By the end of this course, participants will be able to:
- Explore ISO 13485 and its significance in medical device quality management.
- Learn how to maintain and improve a Quality Management System.
- Acquire skills in conducting risk management and process validation in medical devices.
- Ensure regulatory compliance, documentation control, and traceability in medical devices.
- Contribute effectively to quality management initiatives and ensure product safety.
This course is ideal for:
- Quality managers & officers.
- Regulatory affairs & compliance officers.
- Product development &design engineers.
- Internal auditors & quality assurance auditors.
- Those responsible for ensuring product quality and safety.
Course Schedule & Fees
- Kuala Lumpur
- Singapore
- Amsterdam
- Online
- Course Fees
This course will take place in Kuala Lumpur on the following dates:
| 19/05/2025 | 02/06/2025 | 16/06/2025 | 30/06/2025 |
| 14/07/2025 | 28/07/2025 | 11/08/2025 | 25/08/2025 |
| 08/09/2025 | 22/09/2025 | 06/10/2025 | 20/10/2025 |
| 03/11/2025 | 17/11/2025 | 01/12/2025 | 15/12/2025 |
| 29/12/2025 | 12/01/2026 | 26/01/2026 | 09/02/2026 |
This course will take place in Singapore on the following dates:
| 12/05/2025 | 02/06/2025 | 23/06/2025 | 14/07/2025 |
| 04/08/2025 | 25/08/2025 | 15/09/2025 | 06/10/2025 |
| 27/10/2025 | 17/11/2025 | 08/12/2025 | 29/12/2025 |
| 19/01/2026 | 09/02/2026 |
This course will take place in Amsterdam on the following dates:
| 05/05/2025 | 26/05/2025 | 16/06/2025 | 07/07/2025 |
| 28/07/2025 | 18/08/2025 | 08/09/2025 | 29/09/2025 |
| 20/10/2025 | 10/11/2025 | 01/12/2025 | 22/12/2025 |
| 12/01/2026 | 02/02/2026 | 23/02/2026 |
This course will take place Online the following dates:
| 27/05/2025 | 24/06/2025 | 22/07/2025 | 19/08/2025 |
| 16/09/2025 | 14/10/2025 | 11/11/2025 | 09/12/2025 |
| 06/01/2026 | 03/02/2026 |
| Kuala Lumpur | Singapore | Amsterdam | Online |
| USD$ 3,580 | USD$ 5,600 | USD$ 5,600 | USD$ 1,920 |
