The coronavirus pandemic presents all of us with unprecedented challenges. Over the next few weeks and months, the top priority for medical device companies must be producing the necessary products for medical care of the population in sufficient numbers in
Next to the China UDI pilot, we also participate in the closed EUDAMED M2M testing project and already mastered the 1st phase successfully. We operate our own access point which communicates directly with the EUDAMED database. With this we have
As already mentioned in October, we are taking part in NMPA’s UDI pilot phase. This is our progress so far: In order to take part in this pilot project, we created a new Content Package especially for China. After thorough
We are proud to announce that our first EUDAMED project for UDI Platform with a world-leading medical device manufacturer had its first Go-live recently. The implementation based on preconfigured content was possible within 6 weeks. Thanks to the integration of
As the date of application of the EU MDR remains May 26, 2020, the European Commission officially stated that EUDAMED’s launch will be delayed to the date of application for in-vitro medical devices in May 2022. Therefore there is no
As you may have already heard, the European Commission stated that EUDAMED’s launch will be delayed to the date of application for in-vitro medical devices in May 2022. Read the official statement. Nevertheless, the date of application of the EU
Am Donnerstag, 14. November 2019 veranstalten SAP Deutschland, DHC und projektraum36 eine SAP Life Sciences Webkonferenz zum Thema „Optimierung von Prozessen im Pharma und Medizintechnik Mittelstand mittels SAP Best Practice Lösungen (Model Company) On-Premise und in der Cloud.“ Thema der
From July 2019 to June 2020, NMPA is running an UDI pilot to verify the functionality of its UDI database. The go-live of Chinese UDI database is planned with the date of application for implantable devices on October 1st 2020.
Shortly after the product launch of our EUDAMED Content Package, we are happy to announce that the first implementation project for the UDI Platform with EUDAMED Content started recently. Our client, a world-leading medical device manufacturer, establishes its UDI maintenance
The Unique Device Identification (UDI) system is already applicable for years in the United States and will become applicable as part of EU Medical Device Regulation (MDR) in May 2020 as well. Many more countries around the globe