Learn more about the global UDI Challenge and how to get ready for the EU MDR UDI Part in our Webinars and Whitepapers. We will add more Content in the near future – so stay tuned and visit us again soon.

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UDI Platform Factsheet

Achieve UDI compliance - with the UDI Platform by p36.labs

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UDI Platform Overview presentation

UDI Platform - a managed service on SAP Cloud Platform

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Unique Device Identification for Medical Devices

Effizient Handeln: Mit passender UDI-Strategie und cloudbasiertem Ansatz

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News

EU MDR is to be postponed by one year

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

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Statement COVID-19

The corona virus pandemic is currently changing our entire professional and private lives drastically. For us as a company, the top priority is to protect the health of our employees while ensuring ongoing operations. For this reason, we have developed

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Spenden statt schenken – unsere Weihnachtsspende 2019 (German)

Im Geschäftsjahr 2019 haben wir uns dazu entschieden, im Rahmen unserer Weihnachtsgrüße auf Grußkarten und Geschenke für unsere Kunden zu verzichten und wie bereits in vorangegangen Jahren eine Spende für gemeinnützige Zwecke zu tätigen. Dieses Jahr durften unsere Kunden mithilfe

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1st phase of EUDAMED M2M testing mastered

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

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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

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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

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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

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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

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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

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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.

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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

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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

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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

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Unique Device Identification mit SAP für den Mittelstand Webinar Recording (German)

SAP, DHC und projektraum36 / p36.labs haben gemeinsam in diesem Webinar unterschiedliche Lösungsansätze und Umsetzungsstrategien für die aufkommenden Anforderungen im Bereich UDI für EU MDR / IVDR aufgezeigt.   Über den angegebenen Link können Sie sich kostenlos registrieren und das

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Unique Device Identification mit SAP für den Mittelstand (German)

Unser Partner DHC lädt ein zur SAP Life Sciences Webkonferenz mit dem Fokus „UDI mit SAP für den Mittelstand“. SAP, DHC und projektraum36 zeigen gemeinsam in der Webkonferenz, wie Sie die FDA- und die neuen europäischen MDR-Anforderungen zur Unique Device

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