Provide professional IVDR training

DAY 1

PART 1   Introduction to the IVDR

PART 2   Changes in the IVDR-risk classification and conformity assessment

PART 3     Changes in the IVDR-UDI and label

PART 4     Changes in the IVDR-GSPR

PART 5     Changes in the IVDR-PMS system

PART 6     Changes in the IVDR-quality management system

PART 7     Changes in the IVDR-European Authorized Representative, registration, CFS

DAY 2

PART 8     Changes in the IVDR-technical documentation

PART 9     Changes in the IVDR-clinical evidence

PART 10   Changes in the IVDR-risk management

PART 11   Recommendations for the implementation of IVDR transition

PART 12   Q&A

Provide special counseling

Changes in the IVDR-UDI and label

Changes in the IVDR-GSPR

Changes in the IVDR-PMS system

Changes in the IVDR-quality management system

Changes in the IVDR-technical documentation

Changes in the IVDR-clinical evidence

Changes in the IVDR-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 IVDR 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.