Life Science Solutions

SAP Cloud based Life Sciences Solutions

Benefit from agile Cloud Solutions with high Quality Focus
UDI Platform

Achieve UDI Compliance with the UDI Platform of p36.labs

Natively built on SAP Cloud Platform
SAP Integration

Native SAP Integration

Benefit from native Process Integration into your hybrid SAP Landscape

Who we are

What we do

Focus on Quality

Integrated Project and Product Development Lifecycle at p36.labs

News

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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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

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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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