Provide professional MDR training 

DAY 1

PART 1 Introduction to the MDR

PART 2 Changes in the MDR-scope expansion

PART 3 Changes in the MDR-risk classification and conformity assessment

PART 4 Changes in the MDR-UDI and label

PART 5 Changes in the MDR-GSPR

PART 6 Changes in the MDR-PMS system

PART 7 Changes in the MDR-quality management system

PART 8 Changes in the MDR-European Authorized Representative, registration, CFS

DAY 2

PART 9 Changes in the MDR-technical documentation

PART 10 Changes in the MDR-clinical evidence

PART 11 Changes in the MDR-risk management

PART 12 Recommendations for the implementation of MDR transition

PART 13 Q&A

Provide special counseling 

Changes in the MDR-UDI and label

Changes in the MDR-GSPR

Changes in the MDR-PMS system

Changes in the MDR-quality management system

Changes in the MDR-technical documentation

Changes in the MDR-clinical evidence

Changes in the MDR-risk management

Provide European Authorized Representative and registration services 

SUNGO’s companies in the Netherlands and Germany can provide the European Authorized Representative service and the service for registration declaration to local regulatory authorities.

Provide a full set of MDR upgrade counseling services 

This covers all the contents of the above 1, 2 and 3, and also includes the service for rectifying the nonconformities pointed out by the notified body after audit.