The MDR Eudamed Specialists

Taking the pain out of compliance

We are the MDR Eudamed specialists

What we do

We are the only company in the world to have worked directly with the European Commission on MDR Eudamed.

For MDR Eudamed we are available to help you with:

  • Consultancy – Anything you need from data preparation and uploads to eDelivery access points we can help.
  • Support – On-going data and XML support issues, registration and user management.
  • Training – Workshops on the EC’s UDI Device XSD’s, data formats and requirements.
  • Full service – we convert, validate, and upload your data to the EC for you.
  • Data Processing and validation against 100’s of EC business rules.
  • Machine to Machine – eDelivery – Access points – use ours or we can set up and manage yours.

Cost effectiveness, you can Save on resources by using our ‘software as a service‘. This service converts your data from excel/csv to the EC XML formats plus validates it against their 100’s of rules. Reduces the risk of failed and refused EC uploads.

Why reinvent the wheel, our ‘Full service’ has already completed the work.

Whatever assistance you need with MDR Eudamed, we can help. We will do everything we can to ensure your compliance with the MDR Eudamed system is as painless and cost effective as possible.

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Projects and consultancy

The projects to prepare your data to meet the XML and Eudamed business rules are complex and should not be underestimated. Allow us to reduce and manage the Eudamed database complexities and help you meet your Eudamed needs. More…

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Data processing

The preparation of XML data required by the EC is extensive and complex, and will require an IT project. We provide processing tools to process/convert your Excel, JSON, and CSV into the required, correctly formatted package ready for delivery to the EC. Allow us to manage the complexities for you. More…

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Support

Problems preparing your data, problems using the application, problems with the XML, XSD validation, or first registering? We can help. More…

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Data exchange and access points

Machine-to-Machine (M2M) data exchange is a fantastic part of Eudamed. We can assist you in preparing your systems, your access points and, if you prefer, we can even perform the last mile data delivery to the EC for you. More…

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Data validation

The rules surrounding the XML preparation are very complex, with the business rules potentially running into hundreds. Validating against both the XSD and the complex business rules is a major undertaking and not to be underestimated. We can take care of this problem for you. More…

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Training

If you require on- or off-site training for your team on using the MDR Eudamed application, on creating and managing the CEF eDelivery access point or on anything associated with MDR Eudamed then we can help you. More…

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Full managed service

We look after everything for you. Simply provide us with the Excel, CSV or JSON  data and we process it, validate it against the various rules, and finally we submit it to Eudamed for you. We manage all your MDR Eudamed requirements. More…

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Software leasing

Save your IT teams substantial time and expense by leasing our data processing, XML conversion, and validation software. Installed your servers, you will receive regular updates ensuring you will always have the latest EC updated business rules, regardless of their changes. More…

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User Conferences

One of the best ways to learn, understand or interact with fellow MDR Eudamed users is to attend one of our conferences. Find out more about the current release, more about new features coming in the subsequent releases, or share experiences and hear from the experts on how to make your MDR-Eudamed experience easier. Complete our conference surveyMore…

Eudamed user conference survey

Which would be your preferred city to attend a Eudamed user conference?
As part of the Eudamed conference would you or your team members be interested in attending training?
Which training would be of interest to you or your team?
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