UDI.cloud for EUDAMED

From: $150.00 for 1 year with 1 year free trial

Get started today with Innovit’s UDI.cloud for EUDAMED compliance – the most cost-effective, cloud-native SaaS solution to help you become MDR compliant for Device Registration with the European Commission. Simple prepackaged data validations and data maintenance workflow to help prepare your regulatory data for automated UDI submissions to EUDAMED – including Basic-UDI, UDI-DI, Legacy devices, System & Procedure Packs (SPP), Market Info and Container Pack data.

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SKU: MDMEU150 Category:

Introducing EUDAMED.cloud, your ‘UDI.cloud solution for EUDAMED’!

A modern, SaaS platform designed to make your job easier for UDI data submissions to the European Commission. EUDAMED.cloud is designed as a cloud-native system to help you reduce the effort and knowledge required to prepare, validate and submit your product data for regulatory compliance with the EUDAMED system.

KEY BENEFITS:

  • Fully hosted in a secure cloud-native environment with ISO 27000 certification.
  • Your data is fully backed-up with real-time disaster recovery across multiple geographical locations.
  • GAMP5 compliant for system validation with IQ and OQ validation packages included.
  • Annex 11 compliance with comprehensive data versioning with electronic signatures, and audit trail reporting & logs.
  • Pre-packaged with 2-stage or 3-stage workflow for data validation, data maintenance, review & approval before submission.
  • Pre-packaged data validations and code lists to reduce the need for expert knowledge for UDI and Basic UDI data preparation and cleansing.
  • Automated machine-to-machine (M2M) data submission using SOAP XML message formats, and acknowledgement message handling.
  • 1-click access to your submission status and submission history with full on-screen visibility to all acknowledgement messages.
  • Optional machine-to-machine integration to source systems via web services APIs or batch file interfaces (including CSV, Excel or GS1 XML).
  • Self-paced learning with online, audio-visual tutorials to learn the EUDAMED.cloud system and EUDAMED data requirements are your own leisure – anytime, anywhere!
  • A modern, user-friendly experience (UX) that’s accessible using all major web browsers, and built using state-of-the-art Angular Typescript technology (not outdated JavaScript).
  • Extensible to include the management and submission of Vigilance and Post market Surveillance forms and reports (e.g. MIR, FSN, FSCA, PSR, PSUR, Trend reports).

Best of all, you can enjoy the above benefits and capabilities for as little a €150 per month!