[vc_row css=”.vc_custom_1463600795244{margin-bottom: 0px !important;padding-top: 80px !important;padding-bottom: 110px !important;}”][vc_column][vc_row_inner gap=”30″ css=”.vc_custom_1463592469581{padding-right: 15px !important;padding-bottom: 60px !important;padding-left: 15px !important;}”][vc_column_inner offset=”vc_col-md-offset-2 vc_col-md-8″][vc_column_text css_animation=”bottom-to-top” css=”.vc_custom_1532952679558{margin-bottom: 12px !important;}”]<\/p>\n
[\/vc_column_text][vc_column_text css_animation=”bottom-to-top”]
\n[\/vc_column_text][vc_column_text css_animation=”bottom-to-top” css=”.vc_custom_1538649118419{margin-bottom: 60px !important;}”]<\/p>\n
We can help you prepare your medical device data for upload to EUDAMED and syncing with SwissDaMed. Data preparation is not simply about converting it to XML; there is also the validation against the many rules, XSD and the European Commission’s business rules. Failure to validate correctly or to meet the defined business rules will result in your data uploads being rejected by EUDAMED. We have various services to assist you, including Machine-to-Machine (M2M) and Bulk EUDAMED Uploads. Firstly, you must populate our spreadsheet templates with our services, then import these templates, validate the data and convert it to the required XML structure. The MDR template package\u00a0<\/a>and the IVDR template package<\/a> both include numerous built-in EUDAMED rules to assist you. Our Validator and Converter services will take care of the rest, leaving you ready to upload whenever you are ready.<\/p>\n Our web application service ‘The validator’ accepts the uploaded Eudamed spreadsheet(s) you have populated.\u00a0 Our system then prepares PDF files of the spreadsheet data, split into Basic UDI and UDI DI files. The number of UDI DI\u2019s per PDF is managed by the user uploading the spreadsheet in the web app, they have the option to have up to 100 devices in each PDF.<\/p>\n Tip: For easy validation and to make life easier on your data reviewers, the spreadsheets should be split into product family groups. You can also track the various spreadsheet updates within your own document management system so you always have history and backups.<\/p>\n After you upload the spreadsheet file to our web application you receive a message stating the upload was successful, then we start processing in the background when we are complete you will receive an email that contains a link to a zipped file containing all the PDF\u2019s related to the spreadsheet upload. The Basic UDIs have been separated from the UDI DI to ensure faster processing and easier reviewing. Your responsible persons can now review these PDFs to ensure that the spreadsheet data is correctly prepared for an EUDAMED upload.<\/p>\n To facilitate validation, all mandatory fields are highlighted if they are not populated or if errors are detected. Missing or unpopulated sections are highlighted to ensure the reviewer has all the necessary information. The system validates against the European Commission’s business rules, and you are also presented with a list of failed rules if any such failures exist. If your data is error-free, you are ready to convert it to the required XML structure.<\/p>\n Our ‘Converter’ service takes your spreadsheet, revalidates the data for accuracy, and if it is error-free, converts your data into the XML files required by the European Commission. If errors are discovered during the process, the user is alerted via email, which contains a link to the same zip file containing the PDF files created by the Validator, allowing them to be reviewed. If no errors are discovered then the data is converted to XML and you are emailed, this email contains the PDF files for your records and the XML files, you are now ready to submit your data to EUDAMED using the European Commissions EUDAMED ‘Bulk upload’ option. This bulk upload is suitable for small and large amounts of UDI DIs. For example, 15,000 devices can be uploaded in 50 XML files, as the EC allows, in theory, 300 entities per file. Currently, the Bulk Upload is limited to 25 UDI DIs per file due to EUDAMED’s limitations in handling the overall data submission load. The Converter is available via our web application.<\/p>\n Using the ‘Bulk Upload’ option is significantly cheaper than the resource-intensive, owner-managed Machine-to-Machine option, which can cost many times more than the ‘Bulk Upload’ option. However, we do not charge extra for our M2M services; we deliver your data to EUDAMED. M2M is simply transferring your data from A to B. We do that as part of our daily operations.<\/p>\n For all options, if you require the data to be prepared, validated, and delivered to EUDAMED and even SwissDaMed, we can assist you. Contact us with any questions; we will be more than happy to assist you.<\/p>\n We can assist you at every stage of this process, from EUDAMED templates and training to support, data processing, validation of your spreadsheet data, conversion to XML with messages ready for ‘Bulk Upload’ or automatically uploaded to EUDAMED, project management, and ‘machine-to-machine’ (M2M) uploads.<\/p>\n As much assistance as you need, we can provide it. EUDAMED is our business; we are available for “everything EUDAMED”. Let our expertise solve your EUDAMED problems.<\/p>\nThe validator<\/h4>\n
The Converter<\/h4>\n