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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UDI Regulatory Update 05/2020

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 MDR to 26 May 2021.

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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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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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