Your EUDAMED Specialists

Selling Medical Devices in Europe?
You need our EUDAMED Submission Software & Training

We are here to help you with EUDAMED, we offer Training, EUDAMED Submission Software, EUDAMED mobile search app, Bulk Searching for UDI DI’s, Support, and Consultancy, and everything for the European Commission’s MDR and IVDR EUDAMED.

Why Clients Choose Us for EUDAMED Services


Barabra, Canada: “…sessions were packed with key information, presented at a good pace, with lots of time for questions and terrific insights. I highly recommend this course…”

Martine, Netherlands: “Thank you for your support in the past year. We are very happy with Eudamed SAAS and the service provided by you.”

Juan, Spain: “This service saved us a lot of stress when dealing with competent authorities and the European Commission. The team were very helpful both during and after our registration.”

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Training

Exclusive EUDAMED training for your IT team, management, RA and QA professionals on the MDR & IVDR EUDAMED requirements. Read More…

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EUDAMED Software

We validate your UDI device data, prepare it for EUDAMED, auto upload, and help you take care of the rest. Read More…

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EUDAMED Mobile Search App

Search EUDAMED by scanning a UDI DI or the Medical Device label Read More…

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Support

Rely on us to help you register your devices, prepare and validate your UDI data, and meet any other EUDAMED requirements. Read More…

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Projects and consultancy

We can quickly and accurately prepare your data to meet the complex XML and MDR EUDAMED rules. Read More…

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Data exchange and access points

We can help with your machine-to-machine (M2M) data and eDelivery access point choices whether it is in-house or external. Read More…

We are the EUDAMED specialists

What We Do

For EUDAMED we are available to help you with:

  • Training – Confused by EUDAMED? Baffled by the European Commission(EC) publications? We can help with our exclusive EUDAMED training, this medical device database requirements are complex, let us help you gain a clear understanding of what you need to do.
  • Software – we have two software options for you, installed on your server (EudaMed+) or in the cloud (EudaMed SaaS). We convert your data, validate, provide you with the XML and automate the upload of all your device data directly to the European Commission’s EUDAMED for you.
  • Bulk EUDAMED UDI DI Search Importers, Authorised representatives, distributors, and manufacturers “Eudamed Check” is a service to save you time and money when searching EUDAMED for 100’s of UDI DI’s.
  • 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 template.
      • Distributor EUDAMED template.
      • Importer EUDAMED template.
  • 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 EUDAMED, we can help. We will do everything we can to ensure your compliance with the EUDAMED system is as painless and cost effective as possible.

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