MDR-Eudamed requires perfectly prepared XML data for upload to the EC. The XSD’s from the EC are exceptionally complex and come with an exceptional amount of business rules. Understanding these will take your IT team a lot of costly time. Companies can save on IT resources valuable time by bringing us is to consult and not only on the EC requirements, we can also assist with your overall strategy for preparing your systems to integrate with the EC requirements. We are available for expert MDR Eudamed consultancy and/or project management.
Part of the IT project you will need to consider are the data upload options, and the costs financially and in the ongoing IT resource requirements. Upload options include machine-to-machine with your own CEF eDelivery access point or, more cost effectively, using our access point, maintained and supported by Eudamed.eu. Regardless of the option used for upload, the XML must be perfect otherwise your data will be rejected by the EC. Manufacturers and notified bodies will be required to prepare their XML data, not only for validation against the EC’s XSD but also to meet the EC’s complex and extensive business rules.
The size and complexity of these projects should not be underestimated. These will not be one-off data transfers – there will be multiple uploads over many years, including on-going changes and maintenance required. The preparation of the data and the conversion to the correct formats, in order to meet and pass XSD and the business rule validations, takes substantial time and expertise, we can help reduce the burden for you. We are the only company in the world to have had hands on experience with the development and implementation of MDR Eudamed.
Regardless of our involvement in your project, we urge you to start as soon as possible. These projects can take considerable time and depending on the expert assistance you have at your disposal, these projects can be extremely costly and complex.
We have many years’ experience and the necessary expertise in this area to assist you with your project. We have extensive experience in preparing various systems for use with the EC applications. The XSD and XML structures the EC will use for MDR Eudamed are very similar to ones used by many other EC applications. From concept, to design, to implementation, we can take care of this project for you, whether working in conjunction with your IT department, working as part of your team or as a full independent team using the data you provide.
Our team can get your eDelivery access point working and integrated with your delivery systems, also get your REST or SOAP services designed, implemented and delivered using our MDR Eudamed knowledge, in addition to managing and preparing your XML data for upload to MDR-Eudamed. Whatever your needs, we can help.
Eudamed.eu can help at every point of this process from training to support, data processing (JSON, CSV, Excel, to XML), validation of the XML, project management, to uploads. In addition, we offer a full MDR-Eudamed managed service, taking care of everything on your behalf.
We can provide you with as much assistance as you need. MDR-Eudamed is our business. Let our expertise solve your MDR-Eudamed problems. Contact us to see how our services can benefit you.