SAP Cloud based Life Sciences Solutions

Benefit from agile Cloud Solutions with high Quality Focus

Achieve UDI Compliance with the UDI Platform of p36.labs

Natively built on SAP Cloud Platform

Native SAP Integration

Benefit from native Process Integration into your hybrid SAP Landscape

Who we are

What we do

Focus on Quality

Some Title

Update – Lollslauf mal anders (German)

Vergangenen Sonntag fand der letzte Präsenzlauf im Rahmen des 21. Lollslauf in Bad Hersfeld statt. Wir vom projektraum36 haben nicht nur als Sponsor daran teilgenommen, sondern wurden außerdem durch die Teilnahme von Mitgründer Robin Wennemuth (rechts) und Marketing Managerin Celine

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New partnership with atrify

We are happy to officially announce that projektraum36 is now a partner of atrify, one of the world’s leading providers of product information data exchange. This cooperation enables us to offer MedTech companies a holistic end-to-end solution for both data

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Go-Live of p36.io

We are proud to announce that our new website p36.io is now live. Over the past few months we have constantly developed ourselves and our portfolio. For this reason it was very important to us to adapt our website as

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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 (German)

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

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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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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Our Partners

Achieve UDI Compliance with the UDI Platform of p36.labs

Natively built on SAP Cloud Platform

Topics Modul

The UDI Challenge

The Medical Device Regulation (MDR) in the EU becomes effective in May 2020 and draws attention to Unique Device Identification (UDI). Anyway, UDI is a global Challenge.

SAP Integration

Benefit from a native Process Integration into your hybrid SAP Landscape. We support various technologies to seamlessly integrate our SAP Cloud Platform based UDI Platform with your on Premise or Cloud SAP Systems.

Solution

Our UDI Platform is delivered with preconfigured Content Packages specific for the UDI Databases of different Regulatory Agencies. Use it out-of-the-box as a managed Cloud Solution.

Validation

Cloud based solutions need an adapted approach for Computer System Validation (CSV). Learn, how our Validation Partner Chemgineering supports you in validated and qualified operations of the UDI Platform Solution.

Learn more

The global UDI Challenge

Really try to do it on your own?
7 reasons for a cloud-based and SAP integrated approach

  • Concentrate on your Core Business

    The requirements affecting your UDI Processes are driven by external Regulatory Authorities. A Cloud Service Provider is close to the market and implements upcoming requirements timely.

  • Native SAP Integration

    A SAP Cloud Platform based Solution natively integrates with your existing SAP System Landscape. Leverage your existing Product Master Data in your SAP ERP Systems based on Standard Interfaces and optimize your Data Quality using flexible Approval processes.

  • Less Support effort

    An externally managed Cloud solution delivers required Updates and includes Support, thus relieving the burden from your Support Organization.

  • Simplified Ressource Planning

    A managed Cloud Solution scales for you with every Regulatory Authority. You neither need new hardware nor Software Development Ressources.

  • Clear Test and Change Management

    A managed Solution ensures the majority of tests during Changes of the UDI Process. A clear Change Request Handling and traceability ease to estimate the Regression Test efforts for your Validation.

  • Calculable Costs

    A Cloud Provider offers transparent licensing metrics for the Service Subscription. You achieve Planning security on your whole UDI Lifecycle.

  • Compliance

    A managed Solution covers all requirements on the submission handling to UDI Databases worldwide – stay compliant with a validatable Solution.

Get support from our UDI Experts!

Would you like to learn more about UDI from our UDI team? Please drop us a message and we will reach out to you!

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Get a first impression

See more in our Product Demo

Most of your UDI Data is maintained in your ERP already?

With our UDI Platform, we provide a Managed Service for the UDI related Product Data Maintenance, Data Validation and Submission Process.
It enables Medical Device Manufacturers to meet the requirements on Unique Device Identification (UDI) of Regulatory Agencies around the world – fast, flexible and easy to use.

The UDI Platform is natively built on SAP Cloud Platform and integrates seamlessly into your existing hybrid SAP Landscape.

  • Validation of your data
  • Simplified Release-Workflow
  • Submission Management
News

Device Data is ready, but Agency-specifics missing?

With our UDI Platform, we provide a Managed Service for the UDI related Product Data Maintenance, Data Validation and Submission Process.
It enables Medical Device Manufacturers to meet the requirements on Unique Device Identification (UDI) of Regulatory Agencies around the world – fast, flexible and easy to use.

The UDI Platform is natively built on SAP Cloud Platform and integrates seamlessly into your existing hybrid SAP Landscape.

  • Data enrichment
  • Validation of your data
  • Customized Release-Workflow
  • Submission Management
Imprint

Most of your UDI Data shall be managed in a new UDI Solution?

With our UDI Platform, we provide a Managed Service for the UDI related Product Data Maintenance, Data Validation and Submission Process.
It enables Medical Device Manufacturers to meet the requirements on Unique Device Identification (UDI) of Regulatory Agencies around the world – fast, flexible and easy to use.

The UDI Platform is natively built on SAP Cloud Platform and integrates seamlessly into your existing hybrid SAP Landscape.

  • Create new maintenance flows
  • Data enrichment
  • Validation of your data
  • Customized Release-Workflow
  • Submission Management
Knowledge base

Integration Options

It’s your choice: We provide various Integration Options based on SAP Technology. It depends decisive on your current Landscape which Technology is the right one for your Company.  Reach out to us if you would like to know more about your possible Integration Scenario.

SAP ERP S/4 HANA On-Premise S/4 HANA Cloud Other systems
REST
ODATA / CDS
ODATA
SAP SLT *
SAP SDI *
SAP PI *
SAP CPI *
* SLT = SAP Landscape Transformation | SDI = Smart Data Integration | PI = Process Integration | CPI = Cloud Process Integration | Separate licenses needed

Validation Partner

Chemgineering is your partner for compliance topics. As experts for validation and qualification Chemgineering supports your way to the Cloud.

Statement COVID-19

Validation Package

Chemgineering provides a Validation Package for the UDI Platform of p36.labs.
It is based on a CSV approach adapted to the UDI Platform and the specific requirements of the medical device industry to:

  • Introduce and operate the UDI Platform Solution in accordance to the regulatory requirements in Europe and overseas
  • Auditing and audit-proof operating the UDI Platform Solution
  • Pre-built Life-Cycle Documents

The Life-Cycle Documents include:

  • URS-Template
  • Validation-Plan (VP)
  • Risk-Analysis  (RA)
  • Trace-Matrix (TMX)
  • Test-Templates for IQ / OQ and Acceptance tests (PQ)
  • Pre-built final reports for IQ / OQ and PQ
  • Pre-built Validation Report (VR)
  • Examples for User-SOPs (e.g. Administration, Change-Control, Data security, Disaster-Recovery, SLA-Monitoring)

Supplier Audit

Request Audit Report

Supplier Audit

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See our webinars

Read our Whitepapers and Presentations

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

Download

Unique Device Identification for Medical Devices

Effizient Handeln: Mit passender UDI-Strategie und cloudbasiertem Ansatz

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Patrick Pfau Founder

Querdenker, Visionär, Tekkie, Familienmensch – immer auf der Suche nach neuen Herausforderungen. erfahren Sie mehr über Patrick

Patrick Pfau Marketing Manager

Querdenker, Visionär, Tekkie, Familienmensch – immer auf der Suche nach neuen Herausforderungen. erfahren Sie mehr über Patrick

Robin Wennemuth Founder

Analytisch, empathisch, lösungsorientiert, engagiert, humorvoll, lauf- und technikbegeistert – und als Berater in erster Linie Lösungsfinder.

Patrick Pfau Founder

Querdenker, Visionär, Tekkie, Familienmensch – immer auf der Suche nach neuen Herausforderungen. erfahren Sie mehr über Patrick

Patrick Pfau Marketing Manager

Querdenker, Visionär, Tekkie, Familienmensch – immer auf der Suche nach neuen Herausforderungen. erfahren Sie mehr über Patrick

Patrick Pfau Founder

Querdenker, Visionär, Tekkie, Familienmensch – immer auf der Suche nach neuen Herausforderungen. erfahren Sie mehr über Patrick

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