Services

Eudamed.eu offers many MDR Eudamed related services. Our business is helping you with everything from data processing and validation, data preparation, project management and fully managed MDR Eudamed packages. Page down to see our current offerings.
SERVICES

Our services simplify your MDR Eudamed compliance.

We are the MDR Eudamed experts, managing and supporting organisations and their interactions with MDR Eudamed.

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Projects

MDR-Eudamed requires perfectly prepared XML data for upload by Machine to Machine with a CEF eDelivery access point. Additionally 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 complex business rules from the EC.

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. The preparation of the data and the conversion of the data to the correct formats, in order to meet the XSD and pass the business rule validations, takes substantial time and expertise.

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 they can be extremely 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 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, get your REST or SOAP services prepared for using our deployment system in addition to managing and preparing your XML data for upload to MDR-Eudamed. Whatever you need, 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.

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Data processing

We can assist you in the preparation of your data for upload to MDR-Eudamed. Data preparation is not simply a matter of  converting to XML, there is also the validation against the XSD and finally the need to meet the business rules as defined by the EC. Failure to validate correctly or to meet the defined business rules means your uploads of data will not be accepted into MDR-Eudamed.

We can help you with your data preparation, be it validating what you have prepared prior to upload or taking your CSV or JSON data to the next stages of completion.

There are several ways you can get your data into MDR-Eudamed. Firstly, you can upload XML data via the internal MDR-Eudamed upload form or via your own installation of an eDelivery access point, or, finally, manually via the MRD-Eudamed web application. You can prepare the XML data and upload it or you can type the information directly into the web application.

We can assist you with all the above options, if you want the data prepared, validated, and uploaded or typed in for you then we can help you. Contact us with any questions – we will be more than happy to assist you.

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.

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Data validation

MDR-Eudamed data requirements, business rules and data preparation rules are extensive and complex. Let Eudamed.eu ensure that your data meets all of these rules prior to the uploading of your data to the European Commission’s MDR-Eudamed.

Uploading incorrect or invalid data will result in your upload being refused by MDR-Eudamed. The EC has not stated what auditing of uploads will take place. They have not outlined the consequences for multiple upload failures when attempting to upload invalid data.

Let Eudamed.eu make sure your data is valid and compliant in advance of any EC upload.

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.

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Data exchange

The machine-to-machine exchange of data between MDR-Eudamed and end users is one of the biggest improvements in MDR-Eudamed over its predecessor Eudamed 2. The EC will use CEF eDelivery as the transportation layer for machine-to-machine XML uploads. The implementation of eDelivery is not to be underestimated. This is a complex AS4-protocol-based transportation layer.

We, as the MDR-Eudamed experts, can take care of this issue for you. We are what is called a ‘last mile delivery’ company. You can upload your files to us using straightforward REST services or via the application GUI. If you wish we can process the files and then forward them on your behalf to the EC eDelivery system using our access point.

You can upload your XML files to us. We will then forward them to the EC using our access point, without validation processes being used. Or if you wish we also provide full data processing, and validation services to make sure there are no rejected uploads from the EC. We ensure the data in your XML file is validated against the EC’s XSDs and that it meets EC business rules.

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.

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Full managed service

The full managed service is exactly as it sounds – a complete service, including support. You upload your data to us (JSON, Excel, or CSV) including a zip file containing any attached documents, then we do the rest.

We manage the complete data processing and data conversion to the EC’s required XML. The data validation ensures the data not only meets the XSD rules but also that it meets the business rules. After passing all the validation criteria we will upload the data package including attachments to MDR-Eudamed.

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, managing 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 this complete service can benefit you.

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Support

There are many ways Eudamed.eu can support your company when dealing with MDR-Eudamed. This is a very complex application and unless you are using it every day it can be time consuming managing this system.

We can, if you wish, take care of your user management. Validating new users and removing users who have moved on.

Next we will support and assist you with issues relating to the data preparation, XML, XSD data validation, validating against the EC’s business rules and the machine-to-machine data exchange, we provide last mile delivery service using our access point. If you wish to set up your own access point we can assist with that, too.

User management 

We can also act as your user administrator for the MDR-Eudamed application. MDR-Eudamed is our daily business. We are experts in this application, along with its user and data management. We would be more than happy to look after any aspect of the MDR-Eudamed application that you need assistance with.

Data preparation and data exchange

The support package includes assisting you with your XML, the XSD validation and clarification as to why your uploads may fail. Problems with eDelivery or errors on the front end of the application? We can assist you with all of them.

MDR-Eudamed is our business. We are aware it is not your main business, yet this is an application you have to use. Let our expertise solve your MDR-Eudamed problems.

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.

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Software leasing

Some companies prefer to manage all the MDR-Eudamed required data in-house. This is an excellent option for those companies with large enough IT teams to do so, however the size and complexity of these projects should not be underestimated.

We as MDR-Eudamed experts can help with these projects. We can manage everything for you. If you prefer to run the whole project yourself we can provide you with a leased API to convert your data from e.g. JSON or CSV, to the required EC-required XML. This API will not only convert your data to the MDR-Eudamed XML structure, it will also validate it against the specific EC XSD and associated business rules. This will allow you to prepare the correct uploads without the hassle of having to code the conversion utility yourself. All data being uploaded to MDR-Eudamed must pass a validation process otherwise it will be blocked from being uploaded by the system.

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, managing 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.

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Training

MDR-Eudamed is a very complex application, both the web application and the data exchange requirements are very demanding. We can provide training both on your premises and in training centres.

The application training covers how to administrate the application, manage your company’s users, inputting your data correctly, the sequence of steps and data requirements.

These hands-on training sessions cover management of the system, adding devices, linking certificates and separate training sessions on preparing your data for uploads. Machine-to-machine uploads or uploads via the MDR-Eudamed GUI require a complete understanding of the EC XSD requirements, structures and the additional business rules.

Data exchange training covers the XSD requirements, the creation of correctly formatted XML, the eDelivery access node requirements and any other data exchange related items the EC insists on such as the correct packaging and signing of the data uploads.

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 training services can improve your MDR Eudamed understanding.

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User Conferences

MDR-Eudamed is going to be used by in excess of 80,000 manufacturers, sponsors, importers, authorised representatives and competent authorities. It will be managed by the European Commission. The projections are that there could be up to 300,000+ users.

Every organisation and user will have different ideas as to what they expect and need from the system. Eudamed Ltd would like to bring interested groups of users together to share their different experiences, to learn more about the system and the future plans for the system, and finally to try and influence the direction of the system.

In 2019, we plan to hold several one-day conferences at which we will cover subjects like first registration of your organisation, adding and managing users, required validation by a competent authorities and for non-EU manufacturers additionally an authorised representative.

We will give an overview of the application, adding UDIs, devices, linking to certificates and several more informative  sessions. These conferences will help inform your users and administrators of what this incredibly large system, MDR-Eudamed, means for your organisation.

These one-day conferences will be followed by optional hands-on training sessions covering management of the system, adding devices, and separate training sessions on preparing your data for uploads. Machine-to-machine uploads or uploads via the MDR-Eudamed GUI require a complete understanding of the XSD requirements, structures and the additional business rules.  Complete our conference survey

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 conferences can benefit you.