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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Global compliance for UDI

Achieve continuous worldwide UDI Compliance with the UDI Platform

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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

projektraum36 achieves SAP Certification as built on SAP® Cloud Platform

We proudly announce that we achieved SAP certification as built on SAP® Cloud Platform with our UDI Platform solution. The UDI Platform enables medical device manufacturers to handle their UDI related governance and submission processes for multiple regulatory authorities and

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Lollslauf mal anders

Am kommenden Sonntag, den 06. September 2020 startet der alljährliche Lollslauf im Rahmen des Lullusfests in Bad Hersfeld. In diesem Jahr sind wir vom projektraum36 das erste Mal als Sponsor des Lollslaufs dabei. Normalerweise findet das Lullusfest in Bad Hersfeld

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Upcoming webinar with Qunique on September 17, 2020

On September 17, we will be part of the webinar “Transparency – Eudamed and UDI” organized together with Qunique. Our co-founder Patrick Pfau will give a talk on the global strategic implementation of UDI. Join us and sign up at

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UDI Platform 2.2 release

The newest release of our UDI Platform  to version 2.2 is available. We enhanced the usability of the Mass Upload templates and also extended the Page Designer to allow for maintenance of customized field descriptions for each data element. With

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How quality & UDI conformity can be ensured

Patrick Pfau, our co-founder and managing director was part of the T4M webinar series on July 1st. He gave an insight how quality & UDI conformity can be ensured. This topic arises from the MDR which sets the rules for

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p36 will be part of the T4M webinar series on July 1st

On Wednesday, July 1, our co-founder and managing director Patrick Pfau will hold a presentation on “How quality & UDI conformity can be ensured” as part of the T4M webinar series “Shaping the Future of Medical Technology” organized by Messe Stuttgart. Click

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UDI Regulatory Updates published

Our UDI Regulatory Updates are now available on our website as we recently decided to make them publicly available. We regularly present our UDI Regulatory Update within the SAP Roundtable, which is offered for SAP customers and partners, and also

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projektraum36 is now a Solution Partner of GS1 Germany

We are proud to announce that we are now one of GS1 Germany’s Solution Partners and thus also part of the global network of GS1. We are looking forward to speaking the “Global Language of Business” and working together to

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UDI Regulatory Update 05/2020

Published on May 22, 2020 Dear reader, All of us currently live in uncertain times as the coronavirus pandemic presents us with unprecedented challenges. For this reason, the European Parliament has agreed to postpone the Date of Application of the EU

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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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