ISO 13485 Foundation is a training course designed to provide participants with an understanding of the requirements of the ISO 13485 standard, which outlines the quality management system (QMS) requirements for medical device manufacturers and suppliers.
The main objectives of the ISO 13485 Foundation course include:
- Understanding the key concepts and principles of the ISO 13485 standard
- Learning about the requirements for a medical device QMS
- Understanding the importance of risk management in the medical device industry
- Understanding the role of documentation and record-keeping in a medical device QMS
- Learning about the importance of regulatory compliance in the medical device industry.
- Individuals involved in Medical Devices Quality Management
- Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
- Individuals interested to pursue a career in Medical Devices Quality Management