Course Overview
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.
Learning Options
Target audiences
- 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
Schedule Dates
The target audience for the ISO 13485 Foundation course includes individuals who are involved in the development, implementation, and maintenance of a QMS for medical devices, including quality managers, regulatory affairs professionals, and other individuals involved in the medical device industry.
The candidates who wish to join this course are expected to have a basic understanding of quality management principles and concepts and they should be familiar with the medical device industry like the use of its devices.
This course includes case studies study materials and a complete understanding of the ISO 13485 standards and their implementation. CounselTrain offers this course to the aspiring candidates which usually ends in one or two days.
The exam usually consists of 40 to 60 multiple-choice questions and the duration of the exam is comprised of 60 to 90 minutes.