EUDAPrep

IT Documentation Software

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EUDAPrep is a extensive automation tool designed to facilitate the registration process within the European Union's medical device database by extracting and validating data from technical documentation, labels, and instructions for use (IFUs). Its main features include automated ingestion and extraction of information from various document formats, accurate code mapping based on official European medical device classification lists, validation against regulatory requirements, and the generation of submission-ready XML files, all within a streamlined workflow. This solution addresses the challenges faced by medical device manufacturers, regulatory affairs teams, and compliance professionals by simplifying data preparation, reducing manual errors, accelerating submission timelines, and ensuring adherence to EU MDR and IVDR regulations.

EUDAPrep can be found in IT Documentation Software categories.

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EUDAPrep Main Features

• Validation
  The tool checks your data against EC rules so errors are shown before you make your submission.
• Code Mapping
  EUDAPrep finds the correct codes from the official EC list and suggests the most specific ones for approval.
• Record Keeping
  Every device or product run has a record of its data, codes, and validation results for your records.
• Data Extraction
  It reads your documents and pulls out important data fields needed for EUDAMED registration.
• Error Detection
  Errors are found early within the tool, so you can fix problems before submitting to EUDAMED.
• Workflow Support
  It guides you through four steps: uploading documents, reviewing data, mapping codes, and exporting files.
• Export to EUDAMED
  EUDAPrep creates ready-to-upload XML files that match all necessary requirements.
• Document Ingestion
  EUDAPrep can accept PDFs, Word files, and spreadsheets from your devices or product groups.
• Real-Time Code Updates
  Codes are updated automatically when the EC releases new list versions, preventing errors on outdated codes.
• Designed for EU MDR and IVDR
  It is built specifically for the EU medical device registration rules and workflows.

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