1. Brief Description:
The ISO 13485 Medical Devices Quality Management System (QMS) Foundation is a training course designed to provide participants with a basic understanding of the requirements of the ISO 13485 standard for QMS in the medical devices industry.
2. Key Topics:
- Introduction to Quality Management Systems (QMS) in the medical devices industry
- Overview of the ISO 13485 standard for QMS
- Key concepts and requirements of the ISO 13485 standard
- Understanding the relationship between ISO 13485 and other quality management standards
- Benefits and challenges of implementing an ISO 13485 compliant QMS
3. Audience:
This course is intended for individuals who are new to the medical devices industry or quality management, and who seek to gain a foundational understanding of the ISO 13485 standard and its requirements. It is also suitable for those who are involved in the implementation, maintenance, and improvement of QMS in the medical devices industry.
4. Learning Objectives:
By the end of the course, participants will be able to:
- Understand the purpose and benefits of ISO 13485 standard for QMS in the medical devices industry
- Identify the key requirements and concepts of ISO 13485 standard
- Understand the relationship between ISO 13485 and other quality management standards
- Recognize the benefits and challenges of implementing an ISO 13485 compliant QMS
- Gain a foundation to move forward with more advanced ISO 13485 courses and certification.
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