Your EUDAMED Specialists

Taking the pain out of Eudamed compliance

We are a private company with the mission of helping the MedTech industry navigate the European Commission’s MDR and IVDR EUDAMED data requirements.

Download our 2021 brochure for more information.

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Training

If you require on- or off-site training for your IT team, Management, RA and QA professionals, on the MDR & IVDR EUDAMED requirements, our exclusive EUDAMED training is for you. After following our two half-day training sessions you will understand EUDAMED. 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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Software and EUDAMED Templates

You populate our spreadsheet templates with your UDI Device data, then you upload it to our online system and we process the data for you. We validate it against the various rules, and prepared the XML data for you, managing all the requirements. More…

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Data exchange and access points

Machine-to-Machine (M2M) data exchange – we can help with your eDelivery access point choices, in-house or external as a service. More…

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Projects and consultancy

The projects to prepare your data to meet the XML and MDR Eudamed business rules are complex and should not be underestimated. Expert consultancy will help get you there faster and more accurately. Allow us to help you meet the MDR Eudamed challenges. More…

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Access Point Application Integrations

Access points require companies to build custom plugins to integrate their in-house applications with their CEF eDelivery compliant access points, we can help.

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.
  • 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.
  • 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 automated the upload of all your device data directly to the European Commission’s EUDAMED 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 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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