Length of training: 8 hrs.

Price: 4 100,- CZK

The seminar is intended for employees of medical device organizations who are responsible for establishing and maintaining a quality management system in accordance with ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes.

The seminar includes an explanation of the individual requirements of the standard, how to implement them and the subsequent process of certification and maintenance of the established quality management system.

Training programme:

• Terminology in the field of quality management system and medical devices
• ISO 13485:2016 requirements
• Methods of implementing the requirements of the standard
• Certification process

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