Quality Management System for Medical Devices – ISO 13485:2016

10 March
08:00 - 16:00


Together with our partner Scandinavian QMS Solutions you will learn about the requirements for creating, implementing and maintaining a compliant ISO 13485:2016 Quality Management System. This session is recommended for quality and regulatory personnel working within the medical device field.

This training will have the following objectives:

• Introduction to Quality and quality management system
• 7 principles of quality management System
• Introduction to ISO 13485
• Interpret requirements of ISO 13485 in the context
• Risk based approach -integrates risk throughout QMS and product lifecycle
• Regulatory requirements: While the old standard expected that established QMS complies with ISO 13485, the new one now explicitly expects QMS to also comply with all applicable regulatory requirements, including also usability, sterility, Development and maintenance of a QMS
• Continuous improvement of QMS
• Where can you get the guidance and help?
• In-depth training requirement (ISO 13485 2016)- Road map.


• Member NOK 4 000
• Cluster Member NOK 4 500
• Non Member NOK 5 500



Ira Sharma Sankhayan

CEO - Scandinavian QMS Solutions