Digitize with
an edge

Support in
the selection
of suitable
software

Head start for the digitization of your regulatory affairs processes

DigiLab supports you in searching, testing, and selecting the most suitable regulatory affairs software for you. Time-consuming research of possible software solutions? Already accomplished! Development of your fully comprehensive basic requirements? Done and dusted!

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An ideal scenario

All your regulatory information is available for you anywhere, anytime. The data is clear and can be combined in a targeted and meaningful way. A single source of accuracy accelerates your processes and is worth more than gold because it saves costs and reduces errors. This makes it much easier for you to obtain, maintain and secure the sales ability of your products in all target markets.
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Metecon-DigiLab
DigiLab is a project of Metecon GmbH in Mannheim. With more than 50 employees and more than 20 years, we have been supporting manufacturers of medical devices and IVDs in the documentation, approval, and market monitoring of their products.

Since 2019, Metecon DigiLab has been testing software solutions for their suitability for regulatory affairs processes; With us, you save your effort for market research and demo versions. Metecon's entire expertise is at your disposal to ensure the speedy success of your project.
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Our team has been in discussion with the software houses since 2019. We have procured more than 30 demo versions and put them through their paces. Today, we know exactly which software meets which requirements. After all, which company would invest in this effort in advance for research purposes only?

Dr. Jovana Dzalto, Project Management DigiLab

Advantages of digitized RA processes

We have now objectively and neutrally tested more than 30 software tools. We are continually expanding our range: we now also have a selection of PMS software for database searches, reference searches and editing, surveys, PMPF, and PMCF. The next additions will be risk management and QM software.

Acceleration of your RA processes
Acceleration of your RA processes
Single source of truth (consistent instead of redundant data basis )
Single source of truth (consistent instead of redundant data basis )
Cost optimization and error reduction
Cost optimization and error reduction
Information is available irrespective of location
Information is available irrespective of location
Up-to-date and effective work
Up-to-date and effective work
Targeted, purposeful combination of data
Targeted, purposeful combination of data

Step by step through DigiLab

We have already accomplished the first steps on the way to digitized regulatory affairs workflows for you: We defined basic requirements for RA software, prepared a market analysis of available solutions, and procured demo versions of qualified RA software. The result: a pool of appropriate software from which you can select the most suitable tools.

What is missing now is the specific adaptation to the needs of your company.

For this purpose, we have defined a process that takes you to your ultimate goal in three steps: from identifying your individual requirements, through the testing and selection process, to implementation. As a neutral partner, we mediate between you and the respective software providers, bridge the knowledge gaps and support both sides in the successful implementation of digitized workflows for RA processes.

1

Requirements and test data

A selection of qualified software is available - but what are your specific requirements? To answer this question, we first analyze the processes in your company.

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Requirements and test data

2

Test in the DigiLab and selection

The core of our service: In the real digitization lab, we guide you through a guided selection process. Under realistic conditions, we mutually test the configuration of the software, develop workflows and perform processes.

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3

Trial operation and implementation

Almost done: In the last step, we support you and the software provider of your choice in trial operation and efficient implementation in the company. Both in the strategy development and in the implementation.

Learn more about step 3

Trial operation and implementation

1

Requirements and test data

On this basis, we work with you to define the individual requirements for your future RA software. Finally, we create test data from your original data sets in order to set the actual processes in your company as faithfully as possible in the further selection process. You are then ready for the next step.

Our services in the first process step:

  • Analysis of your company-specific processes
  • Origin of individual requirements
  • Creation of test data from your original data closing
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2

Test in the DigiLab and selection

For this purpose, all stakeholders come together in the lab - RA department, IT department, employees of different country groups – and by assigning a computer workstation. Based on our analysis of your specific company processes and using your data, you test the configurations of the software for your respective roles.

The conditions correspond as realistic as possible to the actual processes in your company - with the difference that all participants can exchange information directly and immediately and adjust the processes in real-time. In this way, we create an optimal basis for decision-making, on which you can select your potential upcoming software with confidence.

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3

Trial operation and implementation

The trial run can take place either directly in your company or - if desired - in our digitization lab. The goal is the mutual realization: It works.

We then help you to efficiently implement the new software in your company. At the end, we develop an individual process strategy and implement it together with the software provider.

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Come, try
and digitize


Based on extensive market research

A large, constantly growing selection of software solutions

Independent, accompanied selection process

Testing and workflow development under real-world conditions

In the DigiLab at Metecon in Mannheim



How can your RA digitization succeed? Get to know us and benefit from our no-obligation initial consultation.

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