We are the 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 EUDAMED we are available to help you with:

• Training – Confused by MDR EUDAMED? Baffled by the EC publications? We can help with training on the EC’s EUDAMED requirements, this medical device database is complex, let us help you gain a clear understanding.
• Templates – we have completed the hard work for you, we created MDR, MDD, SPP, IVDR, and IVDD, templates for your EUDAMED Device data preparation. Also available:
  • • Authorised Representative EUDAMED templates.
    • Distributor EUDAMED registry templates.
    • Importer EUDAMED registry templates.
• Software – we convert, validate, provide you with the XML to upload OR using our machine to machine software we can upload your data to the EC for you.
• Consultancy – Anything you need from EUDAMED IT project advice, data preparation and manual XML uploads or uploads using our machine to machine data transfers via eDelivery access points we can help.
• Support – On-going data and XML support issues, registration and user management.
• Machine to Machine – eDelivery – Access points – use ours or we can set up and manage yours.
• Access Point Integration Our extensive experience can help create the required IT plugins.

Training is necessary for companies to make informed decisions, the EC publications are confusing and are leaving companies feeling they are missing information. This is not the case, all the information to proceed with the required change management and IT projects is available, our training will save you time and money in understanding the EC requirements. Our scheduled training dates are available here.

Cost effectiveness, you can save €1000’s by using our software services. These services convert your data to the required European Commission XML formats we also validate your data against their 100’s of rules. Reducing the risk of failed and refused EC uploads. Why reinvent the wheel? investing huge resources, we have already completed the work for you.

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.