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, including Training, Software as a Service, Support, Consultancy, and Machine-to-machine access point management
SERVICES

Our services simplify your MDR Eudamed compliance.

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Training

Eudamed is very complex application with hundreds of different data requirements and business rules. The EC have published many of the documents required for companies to proceed IT projects, the links are available here. Everything companies need to proceed has been published. Because of the complexity we feel training is essential, it will save organisations time and effort in needless research and analysis of the EC requirements.

We provide training both on- and off- site in various managed locations for group training sessions. We provide courses for IT personnel to understand the complexities and dependencies of the EC publications. Courses cover the UDI Device, and the machine to machine Data Exchange, even covering the access point data XML encapsulations needed to send submissions to the EC. In addition to the UDI Device XSD’s, XML formats, application business rules, and how to prepare your data for upload to the EC Eudamed database.

Courses covering the main web application and web input forms, will be available closer to the launch date of MDR Eudamed. This course will cover various MDR Eudamed modules that you will need and use. For example manufacturers will require UDI Device, Vigilance, and User management, where as notified bodies will be more concerned with the certificates module. Several parties will require training on Clinical Investigations and Vigilance.

Our scheduled training dates are available here.

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Software as a Service

Software as a Service, our full managed service is exactly as it sounds – a complete service. For your MDR Eudamed data this includes support, validation, processing, conversion, and last mile delivery to the EC. You upload your data to us, JSON, Excel, or CSV, and any attached documents. Then we do the rest.

We manage the complete data processing, conversion to the EC’s required XML, the data validation ensuring your data not only meets the XSD rules, but also that it meets the extensive business rules. After passing all the validation criteria, we will upload your 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, 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 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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Consultancy

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.

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Machine to machine - Data exchange and access points

The machine-to-machine exchange of data between MDR Eudamed and end user systems is an incredibly useful feature. The EC will use CEF eDelivery access points as the transportation layer for machine-to-machine uploads and downloads.

The implementation of eDelivery is not to be underestimated – this uses a complex AS4-protocol-based transportation layer know as an access point. An access point is required by you and connects to an EC access point. The EC does provide a free access point software called ‘Domibus’ which in itself is not complex however the implementation, configuration, management and application integration with your systems, is most definitely complex.

We, as MDR Eudamed experts, can take care of this issue for you. There are two options for you. 1. We help you install, configure, maintain, manage, and integrate your own access point, with your application, on your own premises OR 2. you can use our access point to delivery your data.

1. We can assist you with the installation, configuration, PKI certificate configuration, set-up and testing of your access point, plus if required general management is available. In addition we can also help you with the integration with your own systems so you can pull and push messages to and from the EC.

2. We are what is called a ‘last mile delivery company’ or ‘3rd party provider’. You can upload your date files (XML, Excel etc.) to us, using straightforward REST services, or using our application GUI. After a successful upload to us, if you wish, we can also process/validate/upload the data for you, or simply upload it, on your behalf, to the EC’s Eudamed database system using our access point.

You can upload your prepared XML files to us. We will then forward them to the EC using our access point, without our 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 all the complex 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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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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Software Leasing

We provide online data processing and data validation services. We provide companies with a template for their data. This is uploaded to us, we process the data converting it to the EC required XML structures and validate it against the numerous business rules.

We are fully aware that not all companies will be happy to upload their data to our service. This is why you can also install our software directly on your server, we will lease you our software.

On your server you will provide the populated data template and your leased software will convert the data to the required XML, in addition to validating it against the EC business and data rules.

If the EC changes rules, this is not a problem, we will supply you with the updated software scripts in a timely fashion.

This option gives you 100% control over your data, it stays on your server in your network and it removes a major development burden. This burden is in the IT development project that your IT teams would need to complete. A project that is required to create and validate the correct EC Eudamed accepted XML structure and data. An additional burden is the ongoing maintenance of the validation code, the business rules and requirements.

Every time the EC updates their rules you will have a short period of time to update your systems. Not only is this a general burden but it also requires expensive IT resources, and resources that are competent in understanding the EC’s complex data structures.

If you are happy to do all the programming required within your own IT teams and you would like to have training on the data structures, XSD’s, business rules and XML structures, then we do provide training, support, and consultancy for companies.

As much assistance as you need – Eudamed.eu can provide it. 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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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.