Length of training: 16 hrs.

Price: 6 300,- CZK

The course is designed for personnel in the position of quality manager who is responsible for maintaining a quality management system in accordance with the requirements of ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes. The course is open to both beginners and experienced quality managers.

It is based on a discussion of the individual requirements of ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes and how they relate to the operations of the organization.

The content of the course includes basic and advanced knowledge and skills of the quality manager, his/her responsibilities and duties, supplemented by practical training, including possible variants of documentation. A significant benefit of the training is the practical experience of the lecturers, highlighting the most common mistakes and ways of finding opportunities for improvement.

Training programme:

Day 1

• Quality management systems - basic principle
• Medical Device Terminology
• Medical Device Legislation
• Requirements of ISO 13485:2016 - Part 1

Day 2

• Requirements of ISO 13485:2016 - Part 2
• Responsibilities of the Quality Manager
• Practical examples from the field of medical devices

Upon completion of the course, the participant will receive a Certificate of Completion.