UDI EUDAMED Webinar
UDI EUDAMED Webinar Global UDI implementation with the right strategy and UDI data management system Date: Tuesday, 26 January 2021 / 4pm (CET) Missed the webinar? Register anyway and we'll…
UDI EUDAMED Webinar Global UDI implementation with the right strategy and UDI data management system Date: Tuesday, 26 January 2021 / 4pm (CET) Missed the webinar? Register anyway and we'll…
UDI for software productsStand-alone softwareAny software that is commercially available and thus represents a stand-alone medical device is subject to UDI requirements. The software version serves as a relevant identification…
Which responsibilities you have as importer according to MDRArticle 13 sets out the general obligations of importers. In addition to similar tests as described for distributors and the notification obligations…
Which responsibilities you have as distributor according to MDRGeneral obligations of distributors are described in Article 14. By means of a sampling procedure, which is representative of the products supplied,…
UDI terms and short-cuts in the medical industry from A-Z that you should know. A B C D E F G H I J K L M N O P…
Which responsibilities you have as authorised representative according to MDR The responsibilities of the authorized representative are described in Article 11 of the MDR Regulation. You will find further details…
The unique device identification initiative for medical devices and in vitro diagnostic medical devices is now an international hot topic and how you, as a manufacturer, respond will affect your…
What is MDR/IVDRLegislationThe new European Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/ 746) replace the existing medical device directives.Since 25.05.2017, the EU regulations, the…
If you are a medical device manufacturer who have to meet the UDI requirements of the european union (EUDAMED) then is this video a must for you.Please enjoy our video. …
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct MarkingFinal guidance from the US Food and Drug Administration pushes back enforcement…