Digitize with
an edge

with matching
software tools

For Software Providers: Your Participation in DigiLab

If your software is convincing, nothing stands in the way of your involvement in DigiLab. If the customer project shows that your software is the right one, we bring you on board for the project. From this point on, we jointly support the customer in becoming fit for his RA future and together lead their digitization project to success.

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Medical device manufacturers face major challenges...

  • The requirements for documentation and approval of medical devices are constantly changing: New regulations ensure that the new processes for market access and market monitoring must be developed.
  • The requirements come from different sources, are complex, and differ in the various countries in which the products should be sold.
  • This generates an immense number of documents; a very large number of people have to work together and sometimes edit the same documents.
  • In the instance of changes in production or changes in legal requirements, individual documents must eventually be adapted.
  • Changes to the documentation must be traceable.
  • The documentation must be available for many years.
  • Medical device manufacturers are also experiencing an increasing shortage of skilled workers: many departments are stretched to the limit in terms of personnel, and young talent is rare.
  • It is extremely important for companies to work quickly and effectively in order to take advantage of profit opportunities through rapid market access or to maintain sales capability in case of existing market access.

Medical devices can only be successfully and legally marketed if manufacturers meet regulatory requirements. These requirements are complex.

...and digitalization of RA processes have it all!

As a result, medical device manufacturers are dealing with large numbers of documents and data that need to be efficiently created, maintained, and delivered across sites. This is a classic application area for software in all industries.

But the required digitization is becoming very difficult for medical device manufacturers:

  • There is a lack of skilled workers and expertise.
  • Products, processes, and companies differ so much that a generally valid evaluation of the software is not possible.
  • Expertise in the regulatory area AND IT is required.
With our mutual support, RA digitization can succeed!

7 reasons for your participation in Digilab

  • 1
    We complement each other perfectly: you have the software, and we have the regulatory knowledge.
  • 2
    As RA experts, we give our customers the security that can help decide on the implementation of an extensive project such as process digitization.
  • 3
    For more than 20 years we have been advising and supporting manufacturers of medical devices in the documentation and market access of their products. Together we adapt your software optimally to the requirements of the medical technology industry.
  • 4
    The development of demos and test environments takes place centrally in Metecon-DigiLab so that you can significantly reduce your effort for this.
  • 5
    We handle the development of customer-specific requirements. You only present your software when it’s clear that this software is interesting for the customer. In this way, you avoid software presentations in the course of which it turns out that the prospective customer needs a completely different solution.
  • 6
    In the presentation with original data of the customer the individual use of software can be worked out in the best way.
  • 7
    We support you in communicating with medical device manufacturers, helping translate RA requirements into technical solutions, finding solutions for implementation, and validating the customer-specific installation.

Objective and verified. Your software in the Digilab

We present the best software solutions objectively and neutrally in the DigiLab. Therefore, there are no costs, fees, premium payments for customer contacts, or resulting sales contracts for you as a software manufacturer associated with participation in DigiLab.

As soon as your software is included in the DigiLab, you will receive a "DigiLab certified" certificate from us. The publication of this certificate on your homepage underlines that not only you yourself are convinced of your software, but also we as objective consultants.


When will you come to DigiLab?

We are obviously curious about the functionality of your software: Is it suitable for risk management, creating surveys, etc.? We will also talk about your and our expectations regarding your admission to DigiLab.

When will you come
to DigiLab?


Your software based on our requirements

We provide you with requirements for the software that are based on the functionality of your software. You introduce the software based on the requirements we have provided you with and present a test version to Metecon. This version can also be used later for customer presentations.

Entry to the DigiLab

We then test your software on: Conformity, usability, flexibility for adaptation to individual processes, authorization concept, willingness and ability to cooperate, and cyber security.
We look forward to meeting you! Learn more about the Metecon DigiLab and arrange your meeting with us now.

Entry to the DigiLab