The MDR EUDAMED Specialists
Taking the pain out of compliance
EudaMed.eu is a private company with the mission of helping the MedTech industry navigate the European Commission’s MDR EUDAMED data requirements.
Download our brochure for more information.
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 technical and non-technical training on the EC’s EUDAMED requirements.
- Templates – we have completed the hard work for you, we created MDR, MDD, SPP, IVDR, and IVDD, templates for your EUDAMED Device data preparation.
-
- Authorised Representative EUDAMED templates.
- Distributor EUDAMED registry templates.
- Importer EUDAMED registry templates.
-
- Software – we convert, validate, provide you with the XML to upload OR upload your data to the EC for you.
- Consultancy – Anything you need from EUDAMED IT project advice, data preparation and uploads to 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 on resources by using our software (software as a service). This service converts your data from excel/csv/json to the EC XML formats plus validates it against their 100’s of rules. Reduces the risk of failed and refused EC uploads. Why reinvent the wheel, we have 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.