Ce-marking Web-based Seminars

Changes in the EU Medical Device Directives 2010 Modifications and the 2012 Recast of the MDD Directives -Changes in the EU Medi This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. Tuesday, March 13, 2012 10: 00 AM PST | 01: 00 PM EST  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ... History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier. Currently they serve different purposes, support different goals, but the TF/ DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/ B9DD. Being aware of the similarities and differences can further concurrent  more...

Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel ...ave to be submitted to the Notified Body for review prior CE-Marking of your product. It is not necessary to include all documents in the design dossier which have already been subject to an ISO/ MDD type Audit by the Notified Body. Examples of documents not necessary to be included are Quality Manuals and related lower-level documents. A brief summary of manufacturing processes (flow chart  more...