Your EUDAMED Specialists
Selling Medical Devices in Europe?
You need our unique EUDAMED Submission Software, Consultancy, & Training
EirMed and KPMG “EUDAMED readiness” survey results
We are here to help you with EUDAMED, we offer Consultancy, Training, EUDAMED Data Submissions, Mobile Search App, and Support. Everything for the European Commission’s MDR, MDD, IVDD, AIMDD, and IVDR EUDAMED.
Why Clients Choose Us for EUDAMED Services
“Your EUDAMED services make the most sense out of all the services I have reached out to by far.” Rachel.
Cindy, Netherlands: “With the Eudamed SaaS tool, we were able to relatively simply register over 500 articles in Eudamed. The support provided was prompt, knowledgeable, and friendly.
My experience with Eudamed SaaS is good. It would have cost me a lot of time to register the articles one by one.”
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.”
Barbara, Canada: “…training 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…”
Holger, Germany: Thank you, Richard Houlihan, for your very interesting and technical detailed training about all features of the upcoming Eudamed database. Richard gave us a deep view inside data structure, XML, their XSDs, and requirements, but hurdles and hidden secrets from behind the curtain too. Thank you again for this very productive and fruitful day in Brussels.”
We are the EUDAMED specialists
What We Do
For EUDAMED we are available to help you with:
- EUDAMED UDI Submissions – 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.
- Consultancy – Anything you need from EUDAMED, project advice/management, steering committees, data preparation and submission, 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.
- 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.
- 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 UDI DIs.
- 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:
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- Authorized Representative EUDAMED template.
- Distributor EUDAMED template.
- Importer EUDAMED template.
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- 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, and 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 hundreds 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.