About Us

We are the MDR Eudamed specialists. Our business is helping you achieve compliance with the MDR Eudamed requirements. Whatever your needs, we can help you. By taking advantage of our extensive EC application expertise, your MDR Eudamed experience will be a very easy one. Page down for more information.
Your MDR Eudamed system and support experts

Here to help with your MDR Eudamed needs

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.

Your MDR-Eudamed needs

As the only company specialising in MDR Eudamed we are perfectly placed to assist you with any and all of your needs and requirements. From general support, to data processing and conversion to XML, to the needs of organisations who want to run MDR Eudamed projects in-house, we are the experts, and we can help you.

We have teams available to prepare your systems on site at your location in addition to teams prepared to assist you with any on-site or off-site data processing needs. If you want your own CEF eDelivery access point for machine-to-machine data exchange or if you wish to avail of our access point, we have solutions to help you.

If you have an MDR Eudamed need that we do not currently cater for, please ask.

We look forward to helping you comply with your MDR Eudamed needs.

Project management

Preparing your systems to produce the EC-required XML in order to meet all the EC set business rules is a major project not to be underestimated.

We have specialist teams that can assist you with the whole process. From preparing the XML for simple upload to preparing and configuring your access point for machine-to-machine data delivery.

Whatever your Eudamed needs – let us help you.

Data processing and last mile delivery

We have prepared systems to process your data, Excel, JSON or CSV. We can convert your data to the required EC XML specifications. Not only can we convert it but we can validate it to ensure it meets the EC rules.

Avoid rejection problems when uploading your data to MDR-Eudamed. Let us process and validate your data. We can even upload it on your behalf.

Let us manage your data processing and validation needs.