First Update: China UDI Pilot

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

READ MORE

1st EUDAMED Go-live

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

READ MORE

UDI Regulatory Update 12/2019

Published on December 6, 2019 Dear reader, exciting times are ahead. Are you still confused about the EUDAMED delay and how it affects the MDR requirements related to EUDAMED implementation? EU MDR may be currently the biggest issue of the

READ MORE

Why UDI is still important for EU MDR despite EUDAMED delay

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

READ MORE

Delay of EUDAMED

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

READ MORE

SAP S/4HANA Webkonferenz für die Life Sciences am 14. November 2019 (German)

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

READ MORE

China UDI pilot

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.

READ MORE

First EUDAMED project for UDI Platform with world-leading medical device manufacturer started

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

READ MORE

Achieve UDI readiness for EU MDR with our EUDAMED Content Package for UDI Platform

    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

READ MORE

p36.labs recognized as being one of the 20 most promising SAP Solution Providers in 2019

We are proud having been recognized as being on of the 20 most promising SAP Solution Providers in 2019 by the CIO Review magazine. Based on our focus on Life Sciences Industry and SAP Cloud Platform solutions, we took the

READ MORE