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


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


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


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


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


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


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


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.


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


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


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


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


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


EU MDR and UDI Update

Together with our Partners SAP, DHC and NNIT we continue our collaborative Webinar series on EU Medical Device Regulation (MDR) and Unique Device Identification (UDI). It is embedded into SAP´s quarterly Life Sciences Regulatory Roundtable. Get an update on recent


Are you ready for UDI and EU MDR?

Together with our Partners SAP and NNIT we invited to a collaborative Webinar on Unique Device Identification (UDI) as central part of the EU Medical Device Regulation (MDR). Learn, how EU MDR affects you as a Medical Device Manufacturer and


projektraum36 publishes UDI Platform in the SAP App Center

Manufacturers of Medical Devices must take action now in order to submit their Product Master Data to Unique Device Identification (UDI) Databases worldwide. After the US Food and Drug Administration (FDA) the EU will follow with its Medical Device Regulation (MDR), becoming


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