About Us

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

We are here to help with all your MDR & IVDR EUDAMED needs

For EUDAMED we are available to help you with:

  • Training – Workshops on the EC’s UDI Device XSD’s, data formats and requirements.
  • Software – XML creation, validation, and submission.
  • Data preparation software – Machine to Machine OR manual upload XML preparation.
  • Consultancy – Anything EUDAMED we can help you with.
  • Support – On-going data and XML support issues, registration and user management.
  • 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.

Cost effective – Eudamed SaaS, you can Save €1000’s using our ‘SaaS option‘. Our SaaS service converts your data from excel to the EC XML formats plus validates it against the European Commission’s 100’s of rules. This greatly reduces the risk of failed and refused EUDAMED uploads.

Cost effective – Eudamed+, this is incredible software, ‘EudaMed+‘ is securely installed on your servers, it will Save €1000’s. Our EudaMed+ software has all the input forms you need, validates your data, and can either prepare XML files for you to upload to EUDAMED or automatically upload your data using our Machine to Machine option (M2M).

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.