EUDAMED was updated (version 2.13. to version 2.14). At a glance it can be said that the update increases usability performance for Competent Authorities and Notified Bodies, especially regarding certificate mangement, SS(C)Ps and their related Basic UDI-DIs. Check out the detailed release notes here.
EUDAMED Update version 2.14 Read More »
New update from MDSAP Audit Approach, at a glance: a) Australia got some more detailed requirements regarding Assessment Technical Documentation and Agreements between Sponsors and Manufacturers b) Update of Design Output requirements for Technical Documentation and DHF c) Auditors shall search for evidence of inclusion of feedback into risk management, both Product and Processes d)
New update from MDSAP Audit Approach – MDSAP-AU-P0002.008 Read More »
Top 4 changes in EUDAMED release v2.10: a) Actors module: Actors can be set to inactive mode – PRRC will not be displayed then – Termination date of a mandate will be displayed b) UDI/Device module: Search UDI’s more detailed – Devices by a manufacturer for which a Competent Authority is responsible – Devices by
EUDAMED release v2.10 Read More »